Fmc - East Lansing

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 29955 Based on document review, interview, and policy review the facility failed to maintain an emergency preparedness program meeting the safety needs of their patient population resulting in potential for adverse outcomes in an emergency for all 181 patients served by the facility. Findings include: 1. Failure to review and update the Emergency Plan at least every two years, and failure to maintain readily accessible documentation to identify patients who needed assistance during an emergency situation in order to perform take off from the dialysis machine. (see tag E-004) 2. Failure to develop and implement policies and procedures based on the facility’s risk assessment and emergency plan. (see tag E-0013) 3. Failure to develop policies and procedures for the safe evacuation from the facility. (see tag E-0020) 4. Failure to develop and implement policies and procedures for sheltering in place. (see tag E-0022) 5. Failure to develop policies and procedures for the use of volunteers or other staffing strategies in the event of an emergency. (see tag E-0024) 6. Failure to develop and implement policies and procedures to address the facility’s role under a declaration of a waiver under section 1135 of the Act. (See tag E-0026) 7. Failure to develop and implement processes for ensuring emergency dialysis equipment is available in an emergency. (see tag E-0028) 8. Failure to develop and implement a communication plan. (see tag E-0029) 9. Failure to develop and implement a communication plan that contains names and contact information of all 181 dialysis patients and all facility staff. (see tag E-0030)”

“CFC-PATIENTS- RIGHTS CFR(s): 494.70 This Condition is not met as evidenced by: 36887 Based on observation, interview, and record review, the facility 1) failed to treat 1 (#17) of 32 patients with dignity and respect, 2) failed to protect patient health information and 3) failed to provide accurate contact information for grievance submission resulting in the potential for a loss of patient rights to all 181 patients treated by the facility. See Specific Tags: V-452 Failure to provide dignity and respect V-455 Failure to protect patient health information V-470 Failure to provide current contact information for external grievance submission”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 26222 Based on interview and record review, the facility failed to review and update the Emergency Plan at least every two years. This deficient practice could result in all facility staff and patients being unprepared in any emergency situation. Findings include: On 9/10/24 at approximately 1415, the Emergency Preparedness binder supplied by the Facility Administrator (FA) was reviewed. Review of the binder found lists of responsible staff with names crossed out and current staff handwritten in. FA stated he did not know where the template was to make the changes, so had handwritten it in. On 9/10/24 at approximately 1500, during interview with FA, when asked how often the Emergency Preparedness Plan is updated, FA replied that it is reviewed and approved at the annual Governing Body meeting. On 9/10/24 at approximately 1510, additional Emergency Preparedness policies were provided, including Issuance of a 1135 Waiver and Facility Disaster Preparedness Checklist. FA stated that these documents were located in a corporate policy database. Record review of the Annual Governing Body Meeting minutes, dated February 28, 2024 noted: “the following facility binders were reviewed and approved: ... Emergency Preparedness Binder”. The meeting minutes did not note any changes made to the binder, or contain any details of Emergency Preparedness Plan review or discussion. On 9/11/24 at approximately 0900, during interview with FA, when discussed that the Governing Body Meeting noted approval of the Emergency Preparedness binder and not additional online policies, FA replied “you’re right, that should be in the binder”.”

“Development of EP Policies and Procedures CFR(s): §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] 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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: 26222 Based on interview and record review, the facility failed to develop and implement policies and procedures based on the facility’s risk assessment and emergency plan, resulting in potential for adverse outcomes in an emergency for all 181 patients served by the facility. Findings include: On 9/10/24 at approximately 1415, record review of the Emergency Preparedness binder supplied by the Facility Administrator (FA) revealed that it did not contain any policies and procedures tailored to the facility’s location. On 9/10/24 at approximately 1445, during interview with FA, when asked if there were additional Emergency Preparedness (EP) documents elsewhere in the facility, FA was unaware. On 9/10/24 at 1510, FA was asked if there were facility policies and procedures specific to EP and stated that he does not know. On 9/10/24 at approximately 1610, FA produced copies of three corporate policies: Facility Disaster Preparedness Checklist, dated 05/01/2023; and Issuance of a 1135 Waiver in a Public Health Emergency dated 04/05/2021. When asked where these were located, FA stated that they were from a corporate policy database. On 9/11/24 at approximately 0900, FA produced a document titled Guidelines for Emergency Preparedness dated 07/03/2023. When asked if this document, and the documents from the corporate policy database provided the day prior were also in the Emergency Preparedness binder, FA replied “no”. No additional facility EP documents were provided by survey exit.”

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(b) Policies and procedures. The [facilities] 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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For OPOs at § 486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 26222 Based on interview and record review, the facility failed to develop and implement policies and procedures for tracking of staff and patients, resulting in potential for adverse outcomes in an emergency for all 181 patients served by the facility. Findings include: On 9/10/24 at approximately 1415, the facility Emergency Preparedness binder was reviewed. The binder did not contain policies or procedures specific to the facility location related to how to track patients or staff in an emergency. On 9/10/24 at approximately 1510, during interview with the Facility Administrator (FA) when asked if there were any additional policies related to shelter in place emergency, FA stated that they would pull the patient schedule. When asked if there was a policy stating that, FA was unsure. No additional policy or procedure for shelter in place was provided by survey exit.”

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(b) Policies and procedures. The [facilities] 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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. This Standard is not met as evidenced by: 26222 Based on interview and record review, the facility failed to develop policies and procedures for the safe evacuation from the facility, resulting in potential for adverse outcomes in an emergency for all 181 patients served by the facility. Findings include: On 9/10/24 at approximately 1415, the facility Emergency Preparedness binder was reviewed. This binder did not contain any specific policies or procedures related to evacuation. A staff list included in the binder was cross referenced with a staff list of home training staff, and home training staff were not present on the staff list in the Emergency Preparedness binder. The patient list in the binder was dated July 2024. On 9/10/24 at approximately 1610, during interview with the Facility Administrator (FA), when asked where additional corporate policies would be located in an emergency, FA replied that would be on his desktop computer. When asked if a desktop computer would be a feasible location for documents during an evacuation emergency, FA stated it would not.”

“Policies/Procedures for Sheltering in Place CFR(s): §403.748(b)(4), §416.54(b)(3), §418.113(b)(6)(i), §441.184(b)(4), §460.84(b)(5), §482.15(b)(4), §483.73(b)(4), §483.475(b)(4), §485.68(b)(2), §485.542(b)(4), §485.625(b)(4), §485.727(b)(2), §485.920(b)(3), §491.12(b)(2), §494.62(b)(3). (b) Policies and procedures. The [facilities] 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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(4) or (2),(3),(5),(6)] A means to shelter in place for patients, staff, and volunteers who remain in the [facility]. *[For Inpatient Hospices at §418.113(b):] Policies and procedures. (6) The following are additional requirements for hospice-operated inpatient care facilities only. The policies and procedures must address the following: (i) A means to shelter in place for patients, hospice employees who remain in the hospice. This Standard is not met as evidenced by: 26222 Based on interview and record review, the facility failed to develop and implement policies and procedures for sheltering in place, resulting in potential for adverse outcomes in an emergency for all 181 patients served by the facility. Findings include: On 9/10/24 at approximately 1415, the facility Emergency Preparedness binder was reviewed. The binder did not contain policies or procedures specific to the facility location related to a shelter in place emergency. On 9/10/24 at approximately 1510, during interview with the Facility Administrator when asked if there were any additional policies related to shelter in place emergency, FA replied that he did not know. No additional policy or procedure for shelter in place was provided by survey exit.”

“Policies/Procedures-Volunteers and Staffing CFR(s): §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.542(b)(6), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] 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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This Standard is not met as evidenced by: 26222 Based on interview and record review, the facility failed to develop policies and procedures for the use of volunteers or other staffing strategies in the event of an emergency, resulting in potential for adverse outcomes in an emergency for all 181 patients served by the facility. Findings include: On 9/10/24 at approximately 1415, the facility Emergency Preparedness binder was reviewed. The binder did not contain any information on the use of volunteers or other emergency staffing strategies for during a staffing emergency. On 9/10/24 at approximately 1510, during interview with the Facility Administrator, when asked if the facility would ever use volunteer staff in an emergency, the FA replied they would not use volunteers and that it is difficult enough to find staff on a routine basis. No additional documentation or explanation of staffing strategies were provided by survey exit.”

“Roles Under a Waiver Declared by Secretary CFR(s): §403.748(b)(8), §416.54(b)(6), §418.113(b)(6)(C)(iv), §441.184(b)(8), §460.84(b)(9), §482.15(b)(8), §483.73(b)(8), §483.475(b)(8), §485.542(b)(7), §485.625(b)(8), §485.920(b)(7), §494.62(b)(7). [(b) Policies and procedures. The [facilities] 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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (8) [(6), (6)(C)(iv), (7), or (9)] The role of the [facility] under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials. *[For RNHCIs at §403.748(b):] Policies and procedures. (8) The role of the RNHCI under a waiver declared by the Secretary, in accordance with section 1135 of Act, in the provision of care at an alternative care site identified by emergency management officials. This Standard is not met as evidenced by: 26222 Based on interview and record review, the facility failed to develop and implement policies and procedures to address the facility’s role under a declaration of a waiver under section 1135 of the Act, resulting in potential for adverse outcomes in an emergency for all 181 patients served by the facility. Findings include: On 9/10/24 at approximately 1415, during record review of the facility’s Emergency Preparedness binder, revealed that the binder did not contain policies or procedures for the facility’s role in the instance of a declaration of a waiver under Section 1135 of the Act. On 9/10/24 at approximately 1510, during interview with the Facility Administrator (FA), when asked if there were any policies or procedures related to the facility’s role under an 1135 Waiver, the FA replied that he did not know what an 1135 waiver was. The surveyor explained examples of blanket 1153 waivers from the Covid pandemic, and the FA still did not know what an 1135 waiver was nor what the facility’s role would be. On 9/10/24 at approximately 1610, a document titled “Issuance of a 1135 Waiver in a Public Health Emergency” dated 04/05/2021 was provided by the FA. The FA stated that this document was found on a corporate policy database. Review of the document revealed that it contained background information on 1135 waivers and information on Special Purpose renal Dialysis Facility (SPRDF), but did not contain any information on what the facility’s role would be in such emergency. No further documentation was provided by survey exit.”

“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: 26222 Based on observation, interview and record review the facility failed to develop and implement processes for ensuring emergency dialysis equipment is available in an emergency, resulting in potential for adverse outcomes in an emergency for all 181 patients served by the facility. Findings include: On 9/10/24 at approximately 1415, during review of the Emergency Preparedness binder, it was noted to not contain policies and procedures specific to emergency equipment and supplies. On 9/10/24 at 1510, during interview, the Facility Administrator (FA) was asked what dialysis equipment and medications were available or designated for emergencies. The FA replied, just the crash cart. 29955 On 9/10/2024 at 1120 staff M, registered nurse, was queried where the emergency grab and go evacuation kit was located. Staff M stated the crash cart was utilized as the emergency grab and go kit. On 9/10/2024 at 1145 review of the crash cart was conducted. The crash cart was observed to contain 13 bags of saline, two sleeves of gauze, and a bag of clamps. The crash cart failed to contain enough supplies to serve all patients during shift change if an emergency were to occur. On 9/10/2024 at 1210 an interview occurred with staff A, the facility administrator. Staff A was queried if the crash cart served as the emergency grab and go evacuation kit. Staff A stated the crash cart did serve as the facility’s emergency grab and go evacuation kit. On 9/10/2024 at 1215 during an interview with staff A, it was asked if a document existed for identifying dialysis patients who would require assistance with discontinuation and take off in case of an emergency. Staff A stated there was not a document to identify patients requiring assistance with emergency take off. On/9/12/2024 at 1020 a document review occurred of the policy titled, “Emergency Medication, Equipment, and Supplies,” dated 5/1/2023, reference # 46865. According to the policy it states, “Emergency Evacuation Box: An emergency evacuation box contains supplies primarily needed to emergently remove needles, cap catheters, and provide saline as needed for every licensed station once the patient is in a secure location. Refer to Emergency Evacuation Box Contents. The box must be light enough in weight to be moved easily by one staff member in the event of facility evacuation. Boxes with carrying handles are recommended. An emergency evacuation box is usually a large tackle box or cooler.””

“Development of Communication Plan CFR(s): §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This Standard is not met as evidenced by: 26222 Based on interview and record review, the facility failed to develop and implement a communication plan, resulting in potential for adverse outcomes in an emergency for all 181 patients served by the facility. Findings include: On 9/10/24 at approximately 1415, the facility Emergency Preparedness binder was reviewed. The binder did not contain a facility specific communication plan. A staff listing within the binder was cross-referenced with home training staff, and revealed that home training staff were not included in the staff listing. On 9/10/24 at approximately 0900, during interview with Facility Administrator (FA), he was unaware that the staff listing in the Emergency Preparedness binder did not include home training staff. No further documentation of a communication plan was provided by survey exit.”

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 26222 Based on interview and record review, the facility failed to develop and implement a communication plan that included names and contact information of all 181 patients and all facility staff, resulting in potential for adverse outcomes in an emergency for all 181 patients served by the facility. Findings include: On 9/10/24 at approximately 1415, the facility Emergency Preparedness binder was reviewed. The binder contained a staff listing with hand written “July 2024” on the top. This list was cross referenced with home training staff, and revealed that home training staff were not included in the staff listing. On 9/11/24 at approximately 0900, during interview with the Facility Administrator, he was unaware that the staff list in the binder did not contain home training staff. 29955 On 9/10/2024 at 1135 during the initial tour of the facility a document review of the binder titled, “Crash Cart Binder,” failed to have an updated list of dialysis patients with emergency contacts and phone numbers. The list dated 5/30/2024 contained inpatient dialysis patients and failed to contain any patients admitted after 5/30/2024 and failed to have home program patients. On 9/10/2024 at 1210 an interview was conducted with staff A, the facility administrator. Staff A was queried how often the “Crash Cart Binder” was to be updated. Staff A stated he was not responsible for updating the binder that it was the responsibility of nursing staff to maintain the binder. On 9/11/2024 at 1515 a review of the “Crash Cart Binder” located in the home therapies dialysis area failed to have an updated list of home dialysis patients with emergency contacts and phone numbers. A list of patients was dated 4/17/2024 and failed to contain any patients admitted after 4/17/2024. Staff C, the manager of the home dialysis department confirmed the findings.”

“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: 36887 Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment resulting in the potential to spread infectious agents to 32 patients currently receiving treatment. Findings include: On 9/10/2024 at 1125, a plant was found to be sitting on the top of the half wall next to Station #13. This was confirmed by Nurse Staff M at the time of discovery. On 9/11/2024 at 1544, Facility Administrator Staff A was informed of the plant being on the treatment floor to which he stated, “There is? We can’t have that?” On 9/11/2024 at 1610, Staff A brought the plant to the conference room and stated the plant was “fake.” Facility policy #47685 titled “General Cleanliness and Infection Control Guidelines” published 7/1/2024 states, “Flowers and potted plants should be restricted from dialysis treatment areas... Artificial and silk plants will not be kept in dialysis treatment rooms or areas.” 22050 On 09/10/24 at 10:40 A.M., A flash tour was conducted with Facility Administrator (FA) “A” and Area Technical Operations Manager (ATOM) “Y”. The following items were noted: On 09/10/24 at 10:55 A.M., The “Laboratory Specimen Refrigerator” external surfaces were observed soiled with adhesive tape residue. Three signs were also observed on the front door face surface, containing adhesive tape residue. On 09/10/24 at 11:30 A.M., 8 of 8 “Germstar Instant Hand Sanitizer” station support columns and drip collection trays were observed soiled with accumulated and encrusted dust, dirt, and debris. 29955 On 9/10/2024 at 1210 a folded vinyl like material was observed lying on top of a trash can in the conference room. On 9/10/2024 at 1215, staff A, the facility administrator was queried about the folded material, and asked what the material belonged to. Staff A stated it was a dialysis chair covering. Staff A was asked to open the material which revealed a brown colored area. Staff A was asked what the brown area might be. Staff A stated, “It’s dried blood.” Staff A discarded the chair cover. On 9/10/2024 at 1410 during observation on the dialysis treatment floor a propped door was noticed leading into the clean supply room. Upon entry to the clean supply room it was revealed the floor contained dropped supplies, dust, and a rodent trap. According to the policy titled, “General Cleanliness and Infection Control Guidelines,” dated 7/1/2024, reference #47685, it states, “All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms and offices. Walkways must be kept clear of debris and free of clutter.””

“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: 36887 Based on observation, interview, and policy review, the facility failed to ensure staff wore gloves and performed hand hygiene after contact with objects in the patient station resulting in the potential for transmission of infectious agents to 32 patients currently receiving treatment. Findings include: On 9/11/2024 at 0958, Patient Care Technician (PCT) Staff J was observed walking into Station #4, wrapping a glove around the right forefinger, silencing the alarm on the machine, and discarding the gloving into the waste bin before walking away. Staff J failed to perform any kind of hand hygiene after leaving Station #4. On 9/11/2024 at 1220, Facility Administrator Staff A was queried as to if it were acceptable to wrap a glove around a finger to touch the machine to which he stated, “No. I’d really like to know who did that. We preach that around here all the time.” On 9/11/2024 at 1206, Certified Clinical Hemodialysis Technician (CCHT) Staff T was observed getting ready to initiate dialysis for a patient with a central venous catheter (CVC). Supplies were brought into Isolation Station #2 and placed on the chairside table. Staff T was observed touching the table and the patient with gloved hands. Staff T then picked up a packaged 2x2 gauze, exited Isolation Station #2 and walked to the nurse’s station. Staff T ripped open the packaging of the 2x2 gauze, grabbed a bottled skin cleaning agent from the counter and poured some of the cleaning agent onto the gauze inside the packaging. While she was doing this, Staff T was explaining the patient had an allergy to Betadine. On 9/11/2024 at 1208, Staff T was queried as to if the cleaning agent were specific to the patient or if it was for general use to which she replied it was for general use. Staff T failed to remove her gloves and perform hand hygiene after touching treatment surfaces and the patient and prior to obtaining clean supplies from a clean area. Facility policy #47663 titled “Personal Protective Equipment” published 11/6/2023 states, “Staff must remove gloves and wash hands after: Patient care, Exposure to blood and body fluids, Touching any surfaces within the patient station...Always perform hand hygiene after glove removal.””

“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: 36887 Based on observation, interview, and record review, the facility failed to ensure clean areas and clean supplies were protected from cross contamination resulting in the potential for transmission of infectious agents to 32 patients currently receiving treatment. Findings include: On 9/10/2024 at 1152 while doing observations on the treatment floor, the door to the clean supply room was found to be propped open. It was noted there was a number lock on the outside of the door and no hangers for personal protective equipment (PPE) were found outside the door. On 9/11/2024 at 0953, Nurse Staff R was observed walking into the clean supply room without removing the PPE cover gown. On 9/10/2024 at 1156, Nurse Staff S was observed walking from Station #30 to the nurses station still wearing her gloves. She then began typing on the laptop computer sitting on the counter. When finished, she removed her gloves and performed hand hygiene. On 9/10/2024 at 1158, Staff S was asked if the nurses station counter were considered clean or dirty to which she replied, “It is clean.” Staff S was then asked why she was typing on her computer still wearing her gloves she had applied in the treatment station. She stated, “I don’t know... I’m so flustered right now.” Facility policy titled “Dialysis Precautions” published 1/4/2012 states, “Clean area: An area designated for clean and unused equipment, supplies and medications. Dirty area: An area where this is a potential for contamination with blood or body fluids and areas where contaminated or used supplies, equipment, blood supplies or biohazard containers are stored or handled. Clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled or stored.” Facility policy #47663 titled “Personal Protective Equipment” published 11/6/2023 states, “All personal protective equipment shall be removed prior to leaving the treatment area... Avoid touching surfaces with gloved hands that will be touched with ungloved hands (for ex. patient charts and computers.)””

“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: 36887 Based on observation, interview, and record review, the facility failed to ensure all surfaces of the treatment station were cleaned between patients resulting in the potential for transmission of infectious agents to 32 patients currently receiving treatment. Findings include: On 9/10/2024 at 1122, Nurse Staff M was observed cleaning Station #4. Staff M failed to clean the tubing at the bottom of the machine, the fitting for the bicarb bag, the inside of the door to the blood pump, the blood pump, the air detector, the mount for a syringe, and the clip for the dialyzer. Additionally, Staff M failed to clean the area between the table and arm of the chair bilaterally, failed to clean the side of the chair under the table bilaterally, and failed to leave the chair open until dry. On 9/11/2024 at 0930, Certified Clinical Hemodialysis Technician (CCHT) Staff T was observed putting new tubing on the machine in Station #15. During this time, the patient whose treatment had just concluded was observed still in Station 15. The patient was packing her belongings into a large bag with the treatment chair being between the patient and the dialysis machine. The patient walked away from the treatment station with her belongings and Staff T then put bleach wipes on the treatment chair. On 9/11/2024 at 0942, CCHT Staff T was queried as to if it were acceptable to be applying new, unused tubing onto the machine when the treatment chair had not been cleaned and the patient was still in the treatment station. Staff T stated, “All of her belongings were on the other side of the chair.” On 9/11/2024 at 0945, Nurse Staff R was queried as to if it were acceptable to clean part of the treatment station and start prepping the machine for the next patient before everything was clean and the patient was out of the treatment station to which she stated, “No.” On 9/11/2024 at 1100, Facility Administrator Staff A stated it was his expectation that staff follow the policy for cleaning of station. He also stated the patient should be gone from the patient station prior to the beginning of cleaning. According to the facility policy titled, “Cleaning and Disinfecting the Dialysis Station,” dated 9/5/2023, reference #47806, it states, “To prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection of the station and set up for the next patient.” 22050 On 09/10/24 at 11:25 A.M., 32 of 32 Water Connection Boxes were observed soiled with accumulated and encrusted with dust, dirt, and debris. (ATOM) “Y” stated: “The clinical technicians should be cleaning the water boxes after each patient.” According to the facility policy titled, “Cleaning and Disinfecting the Dialysis Station,” dated 9/5/2023, reference #47806, it states, “Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood.””

“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: 22050 Based on observation and interview the facility failed to maintain a safe and functional environment resulting in the potential for transmission of infectious agents and injury to the 32 patients being treated at the time of observation. Findings include: On 09/10/24 at 10:40 A.M., A flash tour was conducted with Facility Administrator (FA) “A” and Area Technical Operations Manager (ATOM) “Y”. The following item was noted: On 09/10/24 at 11:15 A.M., the restroom oversink light assembly, adjacent to the Laboratory, was observed emitting minimal illumination. (ATOM) “Y” indicated the restroom had not been used often and needed a new light bulb. On 09/10/24 at 03:45 P.M., a flash tour of the Home Dialysis Center was conducted with Registered Nurse (RN) “U”. The following item was noted: On 09/10/24 at 04:00 P.M., in 2 of the 7 patient treatment rooms, two hand sink cabinet doors were observed to be etched, scored, and chipped. 26222 On 9/10/24 at 1540, during a tour of the home training rooms, training rooms 4 and 5 were observed to have clear plastic sheeting taped on the drain lines under the open countertops. The plastic was observed to be arranged in a way as to be completely connecting the two separate pipes, creating a direct connection between the supply and drain, therefore eliminating the air gap (a physical gap between potable water supply and sewage plumbing to prevent the backsiphonage of sewage into the water supply). During interview with Staff V at this time, when asked why the plastic was present, Staff V stated that it had been there as long as she has worked here and that it was likely installed due to odors coming from the drain.”

“PR-RESPECT & DIGNITY CFR(s): 494.70(a)(1) The patient has the right to- (1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD This Standard is not met as evidenced by: 36887 Based on observation, interview, and record review, the facility failed to ensure patient’s needs are recognized and patients are treated with dignity and respect for 1 (#17) of 32 patients dialyzing on the treatment floor resulting in loss of dignity and the potential for poor patient outcomes. Findings include: During observations on the treatment floor on 9/11/2024 at 1015, P-17 was observed sitting with his feet down in the treatment chair of Station #26. A wheelchair was sitting next to the treatment chair. P-17 had white hair and was overweight. He was leaning to the left side of the chair and neither of his feet were touching the foot tray or the floor. He appeared to make feeble attempts at trying to right himself in the chair by moving his head and arm slightly and made eye contact with the surveyor multiple times. On 9/11/2024 at 1023, P-17 was leaning heavily, with his body twisted, to the left side of the chair. His left arm was on the arm rest with his head hovering above the arm due to a large double chin. His left ribs were touching the arm rest and his buttocks had slid to the right front edge of the treatment chair and his left toes were touching the foot tray while his right toes were touching the floor. On 9/11/2024 at 1028, PCT (Patient Care Technician) Staff X walked into the treatment station, looked at P-17, typed on the machine computer, and walked away. She did not speak to P-17 or attempt to adjust the patient’s position. On 9/11/2023 at 1033, Staff X again walked into the treatment station, typed on the dialysis machine and walked away without speaking or attempting to adjust the patient’s position. On 9/11/2023 at 1033, Registered Nurse (RN) Staff R was queried as to the name of P-17 and Staff X. Staff R asked if anything was wrong and was instructed to look at P-17 and asked if she saw anything wrong. Staff R looked at P-17 and stated, “Oh, he’s sleepy.” On 9/11/2024 at 1040, P-17 continued leaning heavily to the left side. He was no longer attempting to move himself. His head and neck were in the same position unable to rest on anything. His buttocks were still near the right front edge of the chair. His left foot was fully resting on the foot tray and his right foot was almost fully resting on the floor with the heel slightly raised. On 9/11/2024 at 1040, P-17’s primary nurse, Staff M, was queried regarding P-17’s position. Staff M looked over his shoulder and stated, “He’s been like that most of his treatment. He moans and groans when we try to reposition him. (PCT Staff X) is pulling out his second line now and then we will get him into his chair.” Staff M went back to typing on his computer. P-17 remained in that position until staff moved him via Hoyer lift into his wheelchair on 9/11/2024 at 1049. On 9/11/2024 at 1052, RN Staff R stated, “He (P-17) left a couple minutes ago. He is fine. He didn’t fall on the floor.” On 9/11/2024 at 1100, Administrator Staff A was informed about the findings with P-17 and interactions with staff. Staff A was queried as to his expectations for staff with this patient. He stated there was little they could do for P-17 other than complete his dialysis treatment. When queried if they had pillows for support, Staff A stated patients had to bring pillows with them if they were wanted/needed. He was then queried as to if there were any other supportive devices to help P-17 maintain better posture and he stated there were wedges and arm supports that could be used but were not used as “you (surveyors) don’t like them” and stated past citations for storage of the wedges and arm supports. Facility policy titled “Patient Rights and Responsibilities” published 4/4/2012 states, “The Conditions for Coverage, 494.70 Condition: Patient’ Rights require dialysis facilities to inform patients or their representatives of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights. Patients’ rights as stated in the Conditions for Coverage: The patient has the right to - 1. Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD [end stage renal disease]...””

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 36887 Based on observation, interview, and record review, the facility failed to ensure patient medical records were protected from casual access for 2 (P-24, P-25) of 32 patients currently receiving treatment resulting in the potential for unauthorized access to medical information. Findings include: During observations on the treatment floor on 9/11/2024 at 1005, Nurse Staff R was observed typing on a computer at the nurse’s station closest to Station #1. Staff R left the nurse’s station to silence an alarm at Station #1, walked back to the nurse’s station and began typing again on the computer, then walked away, obtained supplies and went back into Station #14. During the whole time, Staff R’s computer screen display remained visible with no screen saver. It was noted that P-24’s name and medical information was visible on the computer screen. On 9/11/2024 at 1013, an unattended computer screen with P-25’s medical information visible was observed in the nursing station closest to Station #32. On 9/11/2024 at 1028, the computer screen changed to black. On 9/11/2024 at 1040, Nurse Staff M was asked if it was common practice to leave the computer screen up when leaving the nurse’s station to which Staff M replied that it was (common practice). Facility policy #COR-ISO-024 titled “HIPAA [Health Insurance Portability and Accountability Act] Policies and Procedures” effective 4/16/2024 states, “All members of [company initials]’s workforce (employees, volunteers, and other persons under the direct control of [company initials]) are required to comply... [Company initials] is committed to protecting the privacy of its patients... Storage of Electronic PHI [patient health information (ePHI). Access to ePHI will be limited to members of [company initials]’s workforce and business associates who require access to perform their duties. ePHI will be maintained in accordance with HIPAA and [company initials]’s Security Policies... A breach is the unauthorized acquisition, access, use, or disclosure of PHI that compromises the security or privacy of the PHI.””

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 29955 Based on document review and interview, the facility failed to provide current contact information for the State Agency and End Stage Renal Disease (ESRD) Network resulting in denying all 181 patients the right to file a grievance with external agencies. Findings include: On 9/10/2024 at 1010 during tour of the dialysis waiting room area, a document review occurred of the information sheet for how to file a complaint/grievance with outside agencies. It was noted that the department and address to file an external grievance with the state agency was incorrect. The information sheet stated “State Agency...State of Michigan, Department of Attorney General, Health Care Fraud Division, P.O. Box 30218 Lansing, MI 48909....” Further review of the information sheet revealed the name and address stated for the End Stage Renal Disease Network was also incorrect. The information sheet stated, “End Stage Renal Disease (ESRD) Network...Renal Network of the Upper Midwest, Inc,1360 Energy Park Dive Suite 200, Saint Paul, MN 55108...”. Further review of the document revealed the name it incorrectly listed the name and address of the stated the incorrect contact information with the End Stage Renal Disease Network contact address as 1360 Energy Park Dive Suite 200, Saint Paul, MN. On 9/10/2024 at 1430, during an interview with staff B, the Director of Operations, it was asked if they knew the contact information for the State Agency and ESRD Network was incorrect. Staff B stated, “No, I did not know it was incorrect...This information is provided by corporate.””

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 36887 Based on observation, interview, and record review, the facility failed to include a nurse in the plan of care meeting for 6 (#16, 18, 19, 20, 21, 22) of 6 patients resulting in the potential of unrecognized, unmet patient needs and poor patient outcomes. Findings include: On 9/11/2024 at 1215 while doing observations on the treatment floor, three women were observed standing around Station #12. On 9/11/2024 at 1225, CCHT (Certified Clinical Hemodialysis Technician) Staff T was queried as to what the women were doing to which she stated, “They are having a POC (plan of care) meeting.” Staff T was then asked where the physician was to which she stated, “Today we have an NP. She is the one with the bun.” Staff T then identified the other two women as Social Worker Staff O and Dietician Staff P. When queried as to where the nurse was, Staff T stated, “(Nurse Staff M) must be doing it today.” On 9/11/2024 at 1230, Nurse Staff M was queried as to if he were doing plan of care conferences today. He stated he was “trying to jump in on the POC chairside meetings as I can. It is very difficult while I’m working on the (treatment) floor.” When queried as to who was filling the nurse role in the interdisciplinary team if he was unable to, he stated, “There is a nurse. The nurse practitioner is there.” He admitted the nurse practitioner was present in the role of the provider. On 9/11/2024 at 1235, Dietician Staff P was queried as to how many POC conferences were scheduled for today to which she stated 6 were scheduled and the last one was at 1630. Staff P stated, “Usually the charge nurse attends the POC meetings but she is not here. (Nurse Staff M) has not been to any today. If we had any nursing questions, we would call him over.” Staff P provided the names of the patients with a POC meeting on 9/11/2024 upon request. Facility policy #45283 titled “Comprehensive Interdisciplinary Assessment and Plan of Care” published 7/3/2023 states, “The Comprehensive Interdisciplinary Assessment and Plan of Care must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, the patient or the patient’s designee, a registered nurse, the patient’s attending physician (or physician extender where allowed by State regulations), qualified master’s degree level social worker and qualified registered dietitian.””

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 48030 Based on document review and interview, the facility failed to analyze and trend patient mortality for 12 (September 2023 - August 2024) of 12 months resulting in the potential for missed opportunities of improvement and less than optimal patient outcomes for all 181 patients served by the facility. Findings include: On 9/12/2024 at 0900 review of Quality Assessment Performance Improvement Committee (QAPI) meeting minutes and Mortality Analysis Log for the past 12 months (September 2023 - August 2024) revealed 34 patients expired. A cause of death was listed for 7 of the 34 expired patients. Of the remaining 27 expired patients, cause of death was listed as “unknown” for 4 patients and 23 patients did not have a cause of death stated, the space provided was blank. On 9/12/24 at 0930, Facility Administrator Staff A was queried regarding regarding blank spaces and “unknown” causes of death for expired patients. Staff A stated he was unaware cause of death was not being recorded. Staff A explained the Charge Nurse is responsible for entering the information. When queried whether analysis or trends related to cause of death was conducted during QAPI meetings, Staff A replied “no”. On 9/12/2024 at 1100 an interview with the Director of Operations Staff B was conducted and revealed she was unaware the cause of death was not being entered. Staff B stated “this is something we always looked at in the past, I did not know this was not being done.” On 9/12/2024 at 1245 an interview with Medical Director Staff Q was conducted. Staff Q verified mortality analysis and trends were not discussed in the QAPI meeting. On 9/13/2024 at 1350 review of facility policy titled “Quality Assessment and Performance Improvement Program”, reference #25799, last revised 5/2/2022, version 5, revealed on page 4 “...QAPI Meeting Objectives...The QAPI Committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 36887 Based on observation, interview, and record review, the medical director failed to ensure staff followed policy on securing the emergency cart resulting in the potential for poor patient outcomes in the event of an emergency for 32 patients currently receiving treatment. Findings include: On 9/10/2024 at 1114, the emergency cart was observed sitting against the wall just outside of Isolation Room #1. It was noted there was a key lock above the drawers and there was an orange break-away lock secured around the top drawer handle. The cart was found to be unsecured when the top drawer was easily pulled open. The top drawer contained multiple items which included three 30 mL (milliliter) vials of Heparin. Other drawers contained emergency equipment such as normal saline 1000 mL IV (intravenous) bags, needles, syringes, oxygen tubing, airway supplies, and the emergency contact list for staff and patients. On 9/10/2024 at 1140, Nurse Staff U was taken to the emergency cart and was queried as to if she had keys for the key lock to which she stated, “No. I don’t think we have any keys for that. I’ve never heard of them anyway.” When asked why there was an intact break-away lock on the top drawer handle, she stated, “I don’t know. It can’t really attach to anything else... This cart is unsecured.” On 9/10/2024 at 1447, Facility Administrator Staff A was queried as to if there were keys for the emergency cart to which he stated, “There are no keys. It is secured with a pull lock.” Staff A was shown a picture of the intact break-away lock secured to the top drawer handle with the drawer opened. He stated, “I guess they (medications, needles, emergency supplies) are unsecured.” On 9/12/2024 at 1245, Facility Medical Director Staff Q was queried whether he was aware the emergency cart was left unlocked with supplies inside and he revealed he was unaware of this but agreed “it should be locked and we should be following the policy for this.” Facility policy #46865 titled “Emergency Medications,, Equipment and Supplies” published 5/1/2023 states, “The emergency cart must be: Locked when not in use.””