Davita Cortez Dialysis Center

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50313 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation § 494.180, Governance, was out of compliance. V-767 The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team- (i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record; (ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge; (iii) Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility; (iv) Contacts another facility, attempts to place the patient there, and documents that effort; and (v) Notifies the State survey agency of the involuntary transfer or discharge. (5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure. Based on interviews and document review, the facility failed to follow all required steps according to the immediate involuntary discharge (IVD) process in one of three patient records reviewed (Patient #2). Specifically, the facility failed to ensure the process for immediate IVD was followed based on the procedure listed in the facility’s policy.”

“GOV-INVOL DISCHARGE PROCESS REQUIREMENTS CFR(s): 494.180(f)(4) The medical director ensures that no patient is discharged or transferred from the facility unless - (4) The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team- (i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record; (ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge; (iii) Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility; (iv) Contacts another facility, attempts to place the patient there, and documents that effort; and (v) Notifies the State survey agency of the involuntary transfer or discharge. (5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure. This Standard is not met as evidenced by: 50313 Based on interviews and document review, the facility failed to follow all required steps according to the immediate involuntary discharge (IVD) process in one of three patient records reviewed (Patient #2). Specifically, the facility failed to ensure the process for immediate IVD was followed based on the procedure listed in the facility’s policy. Findings include: Facility policies: According to the Patient Rights and Patient’s Standards of Conduct, Responsibilities, and Facility Rules policy, patients have the right to be transferred or discharged only for medical reasons, for their own welfare or that of other patients. If they discharged for these reasons, they will be given advance written notice of 30 days unless the reason involves issues of immediate safety. According to the Patient Behavior Agreements, 30 Day Discharge, Involuntary Discharge, or Involuntary Transfer policy, when a facility is considering involuntary discharge, the patient is automatically designated as “unstable” and therefore requires an assessment. The Interdisciplinary Team (IDT) must assess the patient with an intent to identify any potential action or plan that could prevent the need to discharge or transfer the patient involuntarily. If the patient’s behavior is disruptive to the facility, but is non-threatening, a comprehensive patient assessment will be completed by the Interdisciplinary Team (IDT). The assessment must focus on identifying the root causes of the disruptive behavior and result in a plan of care aimed at addressing those causes and resolving disruptive behavior. At the completion of the assessment, a Patient Care Conference (PCC) is required. The IDT should meet with the patient in a conference setting. The PCC will specifically address patient behavior and any patient concerns. The PCC and assessment will be documented in the medical record. If the patient’s behavior continues to be disruptive to the facility, but is non-threatening to others, the patient should receive a First Letter of Concern. This letter will provide specific details of the patient’s behavior and concerns the facility has regarding the patient’s behavior. If at any time teammates or other patients feel an immediate severe threat or safety is a concern, the police should be notified immediately via 911. An immediate severe threat is considered to be a threat of physical harm. For example, if a patient has a gun or a knife or is making credible threats of physical harm, this would be considered an “immediate severe threat”. If it is determined that a patient will be discharged due to the nature of the immediate severe threat, after the emergency is addressed and teammates and other patients are safe the Medical Director, patient’s physician, State agency, and ESRD Network must be notified of the involuntary discharge. This notification and the exact nature of the “immediate severe threat” must be documented in the patient’s medical record. The patient’s physician and facility Medical Director must be notified of the pending involuntary transfer or discharge and provide a signed order. The order will be documented in the patient’s medical record. Reference: According to the Network 15 Involuntary Discharge Process for Dialysis Facilities guideline, involuntary discharge (IVD) should be an option of last resort. Before considering an IVD, the facility should conduct a thorough assessment of the situation and develop a plan to address any problems the patient may be experiencing. The facility must document any impact of behavior on other patients and the staff’s ability to safely provide care. If unable to resolve the problem, and IVD is planned, the facility must obtain a written physician’s order signed by both the medical director and the patient’s attending physician agreeing with the discharge. The facility must provide the patient with a letter of 30-day notice of discharge. An abbreviated involuntary discharge procedure may only be used for immediate severe threats to the health and safety of others. An example of an “immediate severe threat” includes if a patient has a gun or knife or is making credible threats of physical harm. An angry verbal outburst or verbal abuse is not considered an immediate threat. 1. The facility failed to provide evidence of an immediate severe threat which led to Patient #2’s immediate involuntary discharge. Additionally, the facility failed to provide alternative measures prior to an immediate involuntary discharge. A. Record review i. A review of Patient #2’s medical record revealed Patient #2 was admitted to the facility on 4/21/22 for in-center hemodialysis (a process in which a machine filters wastes, salts, and fluid from the body when the kidneys are unable to do this work adequately) with a diagnosis of end-stage renal disease (ESRD) (a medical condition in which a person’s kidneys stop functioning permanently leading to the need for long-term dialysis or a kidney transplant to maintain life). A review of Patient Notes on 8/2/23 at 4:50 p.m. revealed a registered nurse documented Patient #2 continued to be verbally abusive and threatening to staff members and drivers. Patient #2 had been evicted from using local taxi services, and suspended from their alternative means of transport. On 8/26/23 at 3:12 p.m., a registered nurse documented that Patient #2 continued to be very fluid overloaded. Additionally, the registered nurse described that Patient #2 refused to communicate, took things personally, and lashed out at every opportunity. The registered nurse described how engaging in communication with Patient #2 was quite difficult and not pleasant. They also documented the physician was aware of Patient #2’s status and behavior issues. A further review of Patient Notes revealed on 11/22/23 at 12:56 p.m., Patient #2 arrived to their dialysis appointment 30 minutes early. When staff told Patient #2 that a chair was not available, Patient #2 stated they did not want to wait and asked for assistance to call transport. Patient #2 was unable to reach their transportation by phone, and asked to speak with their physician. FA #1 documented that Patient #2 became verbally abusive when they stated to a registered nurse (RN), “you’re prejudice. You don’t know anything.” Facility administrator (FA) #1 documented that Patient #2 was verbally abusive to FA #1 when Patient #2 stated, “You’re prejudice too. You aren’t helping me or anything.” FA #1 instructed Patient #2 to leave the clinic or the police would be called. A review of Patient #2’s Treatment Flowsheet revealed on 2/15/24 at 11:44 p.m. Patient #2 was ambulating with a cane during their appointment. At 3:48 p.m., patient care technician (PCT) #2 described Patient #2 as “awake, alert, and no complaints at this time.” At 3:51 p.m., a registered nurse described that Patient #2 “refused to weigh post-treatment and physically walked into PCT” on their way out. A review of Patient Notes revealed on 2/20/24 at 12:23 p.m., FA #1 called ESRD Network 15 regarding the pending involuntary discharge of Patient #2 for abusive and disruptive behavior. A review of Patient Notes revealed on 2/20/24 at 12:43 p.m. FA #1 called Patient #2’s family member and notified them an involuntary discharge investigation for Patient #2 would be completed that day and Patient #2 would likely be involuntarily discharged due to the 2/15/24 incident. FA #1 described that Patient #2 “pushed a PCT at the end of treatment not causing injury.” Patient #2’s family member requested resources to know where Patient #2 could be treated. There was no evidence of notification or involvement of Patient #2’s physician or the facility’s medical director regarding the involuntary discharge process. This was in contrast to the Patient Behavior Agreements, 30 Day Discharge, Involuntary Discharge, or Involuntary Transfer policy which read, the patient’s physician and facility Medical Director should have been notified of any pending involuntary transfer or discharge and should have provided a signed order. The order should have been documented in the patient’s medical record. Further review of Patient Notes revealed 2/20/24 at 12:54 p.m., FA #1 called the patient and notified them that they had been immediately discharged from the facility due to abusive and disruptive behavior. FA #1 documented that Patient #2 contacted another facility requesting a transfer after being told they were involuntarily discharged. FA #1 told Patient #2 that they would receive a letter from the facility explaining the discharge, and they directed Patient #2 to go to the emergency department for treatment until they were accepted at another facility. This involuntary discharge was in contrast to the Patient Behavior Agreements, 30 Day Discharge, Involuntary Discharge, or Involuntary Transfer policy which read, when a facility was considering involuntary discharge, the patient should have automatically been designated as “unstable” and therefore required an assessment. The Interdisciplinary Team (IDT) should have assessed the patient to identify any potential action or plan that could have prevented the need to discharge or transfer the patient involuntarily. There was no evidence that Patient #2 received an assessment or that the IDT convened to assess the patient and identify any potential actions, or plans, that could have prevented the need to discharge or transfer the patient involuntarily. This immediate discharge was also in contrast to the Network 15 Involuntary Discharge Process for Dialysis Facilities guideline which read, the facility should have documented the impact of the behavior on other patients and the staff’s ability to safely provide care. If an IVD was planned, the facility should have obtained a written physician’s order agreeing with the discharge. The facility should have provided the patient with a letter of 30-day notice of discharge. An abbreviated involuntary discharge should only have been used for immediate severe threats to the health and safety of others, such as a patient with a gun, knife, or who was making threats of physical harm. Angry verbal outbursts or verbal abuse should not have been considered an immediate severe threat. Additional review of Patient Notes revealed on 2/21/2024 at 12:00 p.m., FA #1 left a voicemail with the Colorado Department of Health to notify them of Patient #2’s immediate discharge. B. Interviews i. An interview was conducted on 4/9/24 at 12:46 p.m. with PCT #2. PCT #2 stated they cared for Patient #2 on 2/15/24. PCT #2 stated it was a normal appointment for Patient #2, and that Patient #2 asked to be disconnected early which was typical. PCT #2 stated they were assisting another patient, and Patient #2 reported that they would de-access themselves if not assisted to end treatment early. PCT #2 stated they were instructed by a nurse to take Patient #2 off dialysis. PCT #2 stated Patient #2 was throwing their personal belongings around as they prepared to leave. PCT #2 stated no belongings came into contact with any patients or staff members. PCT #2 stated as Patient #2 was leaving, they refused to be weighed and pushed their body into PCT #2’s shoulder or “shoulder checked” PCT #2. PCT #2 stated they were not injured. PCT #2 stated Patient #2 did not say anything or threaten PCT #2 during this interaction. PCT #2 reported the interaction to a registered nurse, who contacted FA #1. PCT #2 stated FA#1 decided it was unsafe for Patient #2 to return to the facility, so Patient #2 was transferred to another facility. PCT #2 stated dialysis was important to filter out toxins and fluids when patients were in kidney failure. PCT #2 stated the risk of not completing scheduled dialysis included stroke (a condition where blood flow to the brain is blocked or there is sudden bleeding in the brain ), cardiac problems, or heart attack (a condition where part of the heart muscle doesn’t get enough blood resulting injury). ii. An interview was conducted on 4/10/24 at 1:28 p.m. with physician (Physician) #3. Physician #3 stated Patient #2 had a history of transport issues, and it was difficult for them to travel to the facility. Physician #3 stated they were notified by FA #1 on 2/16/24 that Patient #2 had hit or jostled a staff member when leaving the facility after their appointment. Physician #3 stated Patient #2 was moderately impaired, physically frail, walked with a cane, and had potentially impaired vision that could have contributed to jostling a staff member when leaving quickly. Physician #3 stated Patient #2 was vocal about their feelings when upset. Physician #3 stated they did not believe Patient #2 was a threat with respect to physical violence and believed the encounter with a staff member was not intentional but an accident. Physician #3 stated on either 2/20/24 or 2/21/24, they were asked to sign a document approving an involuntary discharge for Patient #2. Physician #3 stated they refused to sign the document. Physician #3 stated the medical director was also asked to sign the involuntary discharge document and refused. Physician #3 stated they were also asked to sign a board of managers letter, and they refused to sign this document. Physician #3 stated they were not notified that the facility was planning to involuntarily discharge Patient #2 until they were given paperwork for signature. Physician #3 stated this process was a unilateral decision, and that the medical director and physicians were not involved in the process. Physician #3 stated they asked FA #1 to organize a meeting for the staff and providers to discuss the issue and then to schedule a meeting with Patient #2. Physician #3 stated Patient #2 should have been placed on a behavioral contract, and continued care at the facility. Physician #3 stated they did not instruct staff to refuse care to Patient #2 after the 2/15/24 treatment. Physician #3 stated they were later told Patient #2 requested to transfer care to another facility. Physician #3 stated they agreed to write transfer orders to the other facility because they were told it was the patient’s choice. Physician #3 stated they had concerns about the facility transfer because it was farther away from the patient’s home and in another state. Physician #3 stated they did not believe that Patient #2’s remaining transport option was able to transport him to the other facility for treatment. Physician #3 stated the risk of an abrupt termination of care or involuntary discharge would be a disruption in the patient’s care. Physician #3 stated after the transfer, Patient #2 was subsequently hospitalized for fluid overload. Physician #3 stated they had been threatened by other patients twice in the past with physical violence, including with a weapon, and did not discharge those patients. Physician #2 stated they had the patients enter a behavioral agreement and continued care. Physician #3 stated there should have been a dialogue with the medical team and patient prior to involuntarily discharging Patient #2. Physician #3 stated they had never discharged a patient so abruptly. iii. An interview was conducted on 4/9/24 at 1:07 p.m. with FA #1. FA #1 stated on 2/15/24 they were notified by a nurse that Patient #2 had “shoulder shoved” PCT #2 when leaving. FA #1 stated they were shocked by this, and attempted to find Patient #2 but Patient #2 had already left the facility. FA t#1 stated they then talked with PCT #2 who stated they were not physically harmed but were upset. FA #1 stated they notified the medical director and Physician #3. FA #1 stated they were told by the medical director and Physician #3 that Patient #2 was older, medically frail, and unlikely to physically harm anyone. FA #1 stated they attempted to contact Patient #2 by phone on 2/16/24. FA #1 stated they contacted their facility’s risk department to discuss the involuntary discharge process, and stated there had been numerous verbal abuse situations with Patient #2 previously. FA #1 stated Patient #2 had never been placed on a behavioral agreement on the advice of the facility’s risk department. FA #1 stated Patient #2 had issues with lack of transportation, causing them to miss treatments. FA #1 stated on 2/17/24, Patient #2 arrived to the facility for their scheduled treatment. FA #1 stated the facility’s risk department told them if Patient #2 received treatment on 2/17/24, then the process for involuntary discharge would be void. FA #1 stated they were directed by Physician #3 to withhold dialysis treatment and to instruct the patient to go home. This was in contrast to the interview with Physician #3 who stated they did not instruct staff to refuse care to Patient #2 and instead wanted Patient #2 to continue care at the facility. This was in contrast to the Patient Behavior Agreements, 30 Day Discharge, Involuntary Discharge, or Involuntary Transfer policy which read, the patient’s physician and facility Medical Director should have been notified of any pending involuntary transfer or discharge and should have provided a signed order. The order should have been documented in the patient’s medical record. FA #1 stated on 2/17/24 a registered nurse talked to Patient #2 when they arrived for their appointment and told them to go home. There was no evidence in the medical record of any discussion with Provider #3 on 2/17/24, or of the encounter and missed treatment scheduled for 2/17/24. There was no evidence that Patient #2 was threatening physical harm or was an immediate severe threat on 2/17/24 when they were instructed to go home and complied with the instruction. FA #1 stated on 2/19/24 they spoke to Patient #2. FA #1 stated the patient wanted to know if they would be allowed to receive dialysis treatment at the facility during their next scheduled appointment on 2/20/24 after being turned away from the facility on 2/17/24. FA #1 stated Patient #2 also wanted to know if they were going to be discharged, and if so where they should receive dialysis treatment. There was no evidence in the medical record of a phone call or conversation with Patient #2 on 2/19/24. FA #1 stated they had contacted risk, the medical director, Physician #3, the regional operations director, and Network 15 regarding the plan to involuntarily discharge Patient #2. FA #1 stated that all were in agreement regarding the involuntary discharge. This was in contrast to the interview with Physician #3 who stated all providers, including the medical director, were not in agreement or consulted regarding the plan to involuntarily discharge Patient #2. FA #1 stated on 2/20/24 they drafted a letter to involuntarily discharge Patient #3, which was approved by the facility’s risk department. FA #1 stated they asked the medical director to sign the IVD letter on 2/20/24, and the medical director refused. FA #1 stated Patient #2 had dialysis treatment scheduled on 2/20/24, but Patient #2 was not welcome back to the facility after 2/15/24. FA #1 stated Patient #2 decided to transfer to another facility and initiated the transfer. FA #1 stated that Patient #1 was transferred on 2/22/24. This was in contrast to the medical record which revealed Patient #2 was told by the facility on 2/20/24 that they had been involuntarily discharged. FA #1 stated Patient #2 did not have a history of previous physical incidents or threats at the facility. FA #1 stated all staff at the facility had been subject to verbal abuse by Patient #2. FA #1 stated an immediate threat would have been actual physical harm, or threatening physical harm. FA #1 stated Patient #2 was an immediate threat because they could have returned to the facility and assaulted PCT #2 or harmed other patients. This was in contrast to the Patient Rights and Patient’s Standards of Conduct, Responsibilities, and Facility Rules policy, which read if a patient had a gun or a knife or was making credible threats of physical harm, that would have been considered an “immediate severe threat.” If at any time teammates or other patients felt an immediate severe threat or safety was a concern, the police should have been notified immediately via 911. There was no evidence that the police were notified due to an immediate severe threat or safety concern. FA #1 stated Patient #2 raising their voice would not result in immediate discharge. This was in contrast to the medical record which stated Patient #2 was told they were being discharged for abusive and disruptive behavior. FA #1 stated other patients at the facility had a history of verbally abusing staff. FA #1 stated the facility organized a care conference with these patients to address the behaviors. FA #1 stated the treating physicians were involved in the care conferences to address behavioral issues, and the patients continued to receive care at the facility. FA #1 stated dialysis was important because it was a life-saving treatment. FA #1 stated the risk of denying a patient access to dialysis was death. FA #1 stated the risk of discharging a patient, or involuntarily transferring a patient, would have been a complication in patient care.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 47962 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.30 Infection Control, was out of compliance. V122 - Procedures for infection control. The facility must demonstrate that it follows standard infection control precautions by implementing-] [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. Based on observations, document reviews, and interviews, the facility failed to ensure patient care staff cleaned and disinfected patient treatment chairs per national guidelines and manufacturer’s instructions for use (IFU) in three of three observations of dialysis station cleaning. V142 - Standard: Oversight. The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; Based on observations, interviews, and document review, the facility failed to ensure staff practices regarding infection control policies and procedures were monitored and followed. Specifically, the facility failed to perform infection control audits. V146 -[Standard: Procedures for infection control. The facility must demonstrate that it follows standard infection control precautions by implementing-] (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.” Based on observations, interviews, and document review, the facility failed to ensure central venous catheter (CVC) (a tubular device inserted into the body to permit injection) exit sites and access threads and hubs were disinfected for the time prescribed by national standards and facility policy in four of four observations of staff accessing CVCs.”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 47962 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.80 Patient Assessment, was out of compliance. V504-Blood pressure and fluid management needs. Based on interviews and document review, the facility failed to ensure staff monitored and reported changes in patients’ blood pressure and documented communication to nursing staff and providers before and during dialysis (the process of filtering a patient’s blood using a machine and filter) treatment based on facility policy. This failure was observed in five of nine dialysis patients medical records reviewed (Patient #2, #3, #5, #6, and #8).”

“CFC-MEDICAL RECORDS CFR(s): 494.170 This Condition is not met as evidenced by: 47962 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.170 Medical Records, was out of compliance. V727 - Standard: Protection of the patient’s record. The dialysis facility must- (1) Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. Based on observations, interviews, and document review, the facility failed to ensure medical records in the peritoneal dialysis (PD) (a treatment that uses the lining of the abdomen to filter a person’s blood) nurse room were stored securely to prevent unauthorized access. This failure affected all 11 of the PD medical records stored at the facility.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 47962 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.180 Governance, was out of compliance. V763 - The governing body- (2) Ensures that all medical staff who provide care in the facility are informed of all facility policies and procedures, including the facility’s quality assessment and performance improvement program specified in §494.110. (3) Communicates expectations to the medical staff regarding staff participation in improving the quality of medical care provided to facility patients. Based on interviews and document review, the facility failed to ensure facility policies were updated and easily accessible to staff. Additionally, the facility failed to ensure the medical staff met regularly and maintained written records of their meetings.”

“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: 47962 Based on observations, document reviews, and interviews, the facility failed to ensure patient care staff cleaned and disinfected patient treatment chairs per national guidelines and manufacturer’s instructions for use (IFU) in three of three observations of dialysis station cleaning. Findings include: Facility policy: The Infection Control for Dialysis Facilities policy read, the purpose of this policy is to minimize the spread of infections or blood-borne pathogens in the dialysis facility environment. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station). Use an appropriate disinfectant such as 1:100 bleach solution for environmental surfaces. Equipment including the dialysis chair and side tables including opening the chair to reach crevices will be wiped clean with a bleach solution of the appropriate strength after completion of procedures, before being used on another patient, throughout the work day, and after each treatment. The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients. Reference: According to the Pure Bright Germicidal Ultra Bleach instructions for use (IFU), for sanitizing work surfaces: cover surface with bleach solution for at least two minutes, and let air dry. According to the Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Cleaning and Disinfection, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm, after each patient treatment, clean environmental surfaces at the dialysis station, including the dialysis bed or chair, countertops, and external surfaces of the dialysis machine, including containers associated with the prime waste. Use any soap, detergent, or detergent germicide. For each chemical sterilant and disinfectant, follow the manufacturer’s instructions regarding use, including appropriate dilution and contact time. 1. The facility failed to ensure staff allowed chairs to remain open until fully dry after cleaning. a. Observations of chair cleanings revealed staff did not allow chairs to dry before the chairs were closed: Examples included: i. On 11/14/23 at 10:39 a.m., an observation revealed staff wiped down the chair in station #17 and closed the chair while visibly wet. ii. On 11/14/23 at 11:14 a.m., an observation revealed staff staff wiped down the chair in station #11 and closed the chair while visibly wet. iii. On 11/14/23 at 3:47 p.m., an observation revealed staff wiped down the chair in station #4 and closed the chair while visibly wet. These observations were in contrast to the Pure Bright Germicidal Ultra Bleach IFU which read, surfaces should have been covered with bleach solution for at least two minutes and allowed to air dry. These observations were also in contrast to the CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Cleaning and Disinfection which read, manufacturer’s instructions regarding use should have been followed when dialysis chairs were cleaned, which included the appropriate dilution and contact time. b. On 11/15/23 at 12:37 p.m., an interview was conducted with patient care technician (PCT) #6. PCT #6 stated it was important to clean chairs properly due to the potential of blood spots being missed. PCT #6 stated blood could be on any surface. PCT #6 also stated chairs were to be washed with bleach solution and allowed to air dry. Additionally, PCT #6 stated patients were at risk of transmissible infections if chairs were not cleaned appropriately. c. On 11/15/23 at 1:15 p.m., an interview was conducted with infection control RN #4. RN #4 stated chair cleaning was required to kill all viruses and bacteria. RN #4 also stated it was expected for bleach solution to be allowed the proper dry time. Additionally, RN #4 stated if all viruses and bacteria were not killed, patients were at risk due to their compromised immune systems. d. On 11/15/23 at 2:06 p.m., an interview was conducted with registered nurse and facility administrator (FA) #1. FA #1 stated chairs were cleaned to ensure bacteria was absent before other patients received dialysis. FA #1 also stated if the bleach solution was not dry, bacteria would not be eradicated. These interviews were in contrast to observations which revealed the chairs were closed when visible wet. e. On 11/14/23 at 12:52 p.m., an interview was conducted with medical director (Director) #5. Director #5 stated improper chair cleaning was a low infection control risk. This was in contrast to the Infection Control for Dialysis Facilities policy which read, the purpose of this policy was to minimize the spread of infections or blood-borne pathogens in the dialysis facility environment. Equipment including the dialysis chair and side tables including opening the chair to reach crevices was to be wiped clean with a bleach solution of the appropriate strength after completion of procedures, before being used on another patient, throughout the work day, and after each treatment.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 47962 Based on observations, interviews, and document review, the facility failed to ensure staff practices regarding infection control policies and procedures were monitored and followed. Specifically, the facility failed to perform infection control audits. (Cross-reference: V122, V146) Findings include: Facility policies: According to the Continuous Quality Improvement Program policy, the purpose is to improve patient safety and outcomes including the reduction of medical errors in accordance with the Quality Assessment and Performance Improvement (QAPI) requirements in the Center for Medicare and Medicaid (CMS) Conditions for Coverage. The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include infection control. According to the Infection Control Policy, revised April 2019, the purpose is to minimize the spread of infections or bloodborne pathogens in the facility. The facility medical director and the Quality Improvement committee will be made aware of infection control issues. The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients. Reference: According to the Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm, preventing transmission among chronic hemodialysis (process of filtering the blood using a machine and a filter) patients of bloodborne viruses and pathogenic bacteria from both recognized and unrecognized sources of infection requires implementation of a comprehensive infection control program. The components of such a program include infection control practices specifically designed for the hemodialysis setting, including surveillance. The infection control practices recommended for hemodialysis units will reduce opportunities for patient-to-patient transmission of infectious agents, directly or indirectly via contaminated devices, equipment and supplies, environmental surfaces, or hands of personnel. These practices should be carried out routinely for all patients in the chronic hemodialysis setting because of the increased potential for blood contamination during hemodialysis and because many patients are colonized or infected with pathogenic bacteria. Furthermore, surveillance for infections is required to monitor the effectiveness of infection control practices, as well as training and education of both staff members and patients to ensure that appropriate infection control behaviors and techniques are carried out. 1. The facility failed to ensure infection prevention and control audits were performed. a. Upon request, the facility was not able to provide documentation revealing infection control audits had been performed over the past year. b. On 11/15/23 at 2:06 p.m., an interview was conducted with facility administrator (FA) #1. FA #1 stated registered nurse (RN) #4 was the infection prevention nurse. FA #1 stated infection prevention audits were to be completed every month, however, she could not find any documentation these had been performed over the past year. FA #1 stated infection control audits were important to prevent staff from becoming complacent in their work and not being mindful of infection prevention techniques. c. On 11/15/23 at 1:15 p.m., an interview was conducted with infection prevention RN #4. RN #4 stated she was not aware she was the infection control nurse, did not participate in facility meetings to discuss infection prevention, and did not perform audits of the staff for infection control purposes. d. On 11/14/23 at 12:52 p.m., an interview was conducted with medical director (Director) #5. Director #5 stated having proper infection control practices was important to prevent infections which could lead to poor patient outcomes, such as abscesses (pockets of dead white blood cells and bacteria). These interviews were in contrast to the Continuous Quality Improvement Program policy which read, the purpose was to improve patient safety and outcomes. The facility measured, analyzed and tracked quality indicators and other aspects of performance, including infection control. These interviews were also in contrast to the Infection Control Policy which read, the purpose was to minimize the spread of infections or bloodborne pathogens in the facility. The facility medical director and the Quality Improvement committee was made aware of infection control issues.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 47962 Based on observations, interviews, and document review, the facility failed to ensure central venous catheter (CVC) (a tubular device inserted into the body to permit injection) exit sites and access threads and hubs were disinfected for the time prescribed by national standards and facility policy in four of four observations of staff accessing CVCs. Findings include: Facility policies: The Central Venous Catheter with Clear Guard HD Antimicrobial End Caps Procedure policy read, perform hand hygiene, put on clean gloves. Set up a clean field with all appropriate supplies on a clean, moisture-proof barrier. Place the second moisture-proof barrier under catheter limbs. Remove old dressing and discard. Remove gloves and discard. Perform hand hygiene per procedure and re-glove. Holding the catheter with the non-dominant hand and using aseptic (a practice aimed at excluding harmful organisms) technique, clean exit site with 2% Chlorhexidine Gluconate / 70% Isopropyl Alcohol swab for a minimum of 30 seconds. Then wait 60 seconds for air dry time. Clean each CVC limb/cap with a new large alcohol prep pad. Remove gloves and discard, perform hand hygiene per procedure, and re-glove. Place sterile 2x2 gauze over the catheter exit site. Remove gloves and discard, perform hand hygiene per procedure and re-glove. Holding catheter with non-dominant hand, use other hand to place sterile 4x4 under catheter limbs. 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, threads and end of hub thoroughly with friction. Hold the limbs until the antiseptic has dried. Upon completion of dialysis (process of filtering the blood using a machine and a filter), perform hand hygiene per procedure. Discard used barrier that was used during treatment and place a new clean, moisture-proof barrier under catheter to prevent contamination. Remove gloves and discard, perform hand hygiene per procedure and re-glove. Clamp arterial catheter limb and blood line. Aseptically disconnect arterial blood line from arterial CVC limb. Attach a syringe filled with normal saline to arterial catheter limb. Unclamp arterial catheter limb and push normal saline into arterial port and quickly clamp arterial catheter limb. Attach arterial blood line to saline infusion line and conclude dialysis and rinse back per procedure. Clamp venous catheter limb and blood line. Aseptically disconnect venous blood line and connect syringe with normal saline to the venous catheter limb. Unclamp venous catheter limb and push normal saline into venous port and quickly clamp venous catheter limb. Remove syringes and disinfect the CVC hubs with a new alcohol prep pad for each CVC hub. Scrub the sides, threads and end of hub thoroughly with friction for 15 seconds. Hold the catheter until the antiseptic has dried. While holding the shield and catheter hub in one hand, remove the single ClearGuard HD cap, and carefully insert into the catheter hub and using a simultaneous push and twist motion, tighten by rotating clockwise. Repeat with the other cap. According to the Infection Control Policy, revised April 2019, the purpose is to minimize the spread of infections or bloodborne pathogens in the facility. The facility medical director and the Quality Improvement committee will be made aware of infection control issues. The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients. Reference: According to the Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Cleaning and Disinfection, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm, for each chemical sterilant and disinfectant, follow the manufacturer’s instructions regarding use, including appropriate dilution and contact time. 1. The facility failed to ensure direct care staff disinfected central venous catheter access threads and hubs according to national standards and facility policy. A. Observations i. On 11/13/23 at 3:38 p.m., an observation was conducted of a CVC discontinuation at station #17. Patient care technician (PCT) #14 removed the syringes from the CVC hubs, scrubbed the venous hub for two seconds, and immediately applied the venous cap. She removed the syringe from the arterial hub, scrubbed the arterial hub for seven seconds, and immediately applied the arterial cap. PCT #14 did not permit time for the hubs to air dry in between scrubbing with an alcohol pad and applying the caps. Additionally, in contrast to the observation of scrub times on the CVC hubs, PCT #14 stated the hubs were scrubbed with alcohol for 15 seconds each during an interview conducted at the time of the observation. This was in contrast to the Central Venous Catheter with Clear Guard HD Antimicrobial End Caps Procedure which read, syringes were removed and CVC hubs were disinfected with a new alcohol prep pad for each CVC hub. The teammate scrubbed the sides, threads and end of the hub thoroughly with friction for 15 seconds then held the catheter until the antiseptic dried. ii. On 11/14/23 at 7:46 a.m., an observation was conducted of a CVC initiation at station #9. PCT #13 swabbed the CVC exit site with a 2% Chlorhexidine Gluconate / 70% Isopropyl Alcohol swab for 19 seconds. PCT #13 later removed the CVC caps, scrubbed the CVC hubs, and immediately attached syringes to the venous and arterial limbs. She did not permit time for the hubs to air dry in between these steps. Also, in contrast to the observation of swab times for the exit site, PCT #13 stated the Chlorhexidine swab was used for 30 seconds on the CVC exit site during an interview conducted at the time of the observation. This observation was in contrast to the Central Venous Catheter with Clear Guard HD Antimicrobial End Caps Procedure which read, exit sites were cleaned with 2% Chlorhexidine Gluconate / 70% Isopropyl Alcohol swab for a minimum of 30 seconds. Using aseptic technique, the teammate removed each cap then scrubbed each CVC hub for 15 seconds including the sides, threads and end of hub thoroughly. The teammate then held the limbs until the antiseptic dried. iii. On 11/14/23 at 7:27 a.m., an observation was conducted of a CVC initiation at station #17. PCT #12 removed the venous cap, scrubbed the hub and then immediately attached a syringe. She removed the arterial cap, scrubbed the hub and then immediately attached a syringe. PCT #12 did not permit time for the hubs to air dry in between these steps. In contrast to the observation, PCT #12 stated the hubs were allowed to air dry for 30 seconds during an interview conducted at the time of the observation. This observation was in contrast to the Central Venous Catheter with Clear Guard HD Antimicrobial End Caps Procedure which read, the teammate removed each cap then scrubbed each CVC hub thoroughly. The teammate then held the limbs until the antiseptic dried. iv. On 11/14/23 at 10:19 a.m., an observation was conducted of a CVC discontinuation at station #17. PCT #12 removed the syringes from the CVC hubs, scrubbed the venous hub, and immediately applied the cap. She removed the syringe from the arterial hub, scrubbed the arterial hub, and immediately applied the cap. PCT #12 did not permit time for the hubs to air dry in between scrubbing with an alcohol pad and applying the caps. This was in contrast to the Central Venous Catheter with Clear Guard HD Antimicrobial End Caps Procedure which read, syringes were removed and CVC hubs were disinfected with a new alcohol prep pad for each CVC hub. The teammate scrubbed the sides, threads and end of the hub thoroughly then held the catheter until the antiseptic dried. B. Interviews i. An interview was conducted on 11/15/23 at 12:37 p.m. with PCT #6. PCT #6 stated it was important to follow CVC policies and procedures in order to eliminate the risks of bacterial infections in the patients. ii. An interview was conducted on 11/15/23 at 1:15 p.m. with infection control registered nurse (RN) #4. RN #4 stated she monitored and educated staff in order to prevent infection control issues with CVCs. She stated she was concerned with the consequences of infections if the staff were to practice poor infection control techniques in this vulnerable patient population. iii. An interview was conducted with facility administrator (FA) #1. FA #1 stated it was important to follow the correct procedure for CVC initiation and discontinuation in order to eliminate bacteria with direct access to the bloodstream which would increase the risk of poor patient outcomes. iv. An interview was conducted on 11/14/23 at 12:52 p.m. with medical director (Director) #5. Director #5 stated proper infection control practices were important to prevent catheter infections which could lead to brain abscesses (pockets of infectious material) and potentially death.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 47962 Based on interviews and document review, the facility failed to ensure staff monitored and reported changes in patients’ blood pressure and documented communication to nursing staff and providers before and during dialysis (the process of filtering a patient’s blood using a machine and filter) treatment based on facility policy. This failure was observed in five of nine dialysis patients medical records reviewed (Patient #2, #3, #5, #6, and #8). Findings include: Facility policy: According to the Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment policy, the nursing assessment will be performed and documented by a registered nurse (RN) and includes physical assessment of the patient. Pre-treatment data collection/assessment: Any abnormal findings or findings outside of any patient-specific physician-ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the nurse. If an abnormal finding is reported to the nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. The nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. During intradialytic data collection/assessment, monitoring and data collection performed by the patient care technician (PCT) or nurse includes vital signs and treatment monitoring completed at least every thirty minutes. At a minimum, obtain and document blood pressure, heart rate, blood and dialysate flows, arterial and venous pressures, fluid removal and/or replacement, vascular access visible and line connections intact, and patient subjective statements. Abnormal findings will be reported to the nurse immediately. The nurse will use clinical judgment to determine if any clinical interventions are necessary. All findings, interventions and patient response will be documented in the patient’s medical record. The following are considered abnormal findings and should be reported to the nurse and documented in the patient’s medical record: intradialytic blood pressure (BP) difference of 20 point increase or decrease from the patient’s last intradialytic treatment BP reading. Members of the patient care team should report any changes in patient conditions or concerns of patient well-being immediately to the nurse at any time. Reference: According to the Patient Parameters provided by the facility, intradialytic (during dialysis) parameters reportable to the charge nurse included systolic blood pressure over 180 or under 100 and diastolic blood pressure over 100 or under 60 and pulse rate over 100 or under 55. 1. The facility failed to ensure PCTs and RNs monitored and reported changes in patients’ blood pressure and documented communication to nursing staff and medical providers during intradialytic treatment based on facility policy. A. Medical Record Review i. A review of medical records revealed Patient #6 was started on dialysis on 11/6/23 with a blood pressure outside of facility parameters. a. A review was conducted of Patient #6’s medical record. The treatment flow sheet revealed on 11/6/23 at 7:45 a.m., Patient #6’s BP was 205/94 at the onset of dialysis treatment. The treatment nurse assessment entered on 11/6/23 at 7:49 a.m. revealed Patient #6’s pre-treatment standing BP was 219/107 and her pre-treatment sitting BP was 218/114. A review of the medical record did not reveal evidence the nurse or physician was notified of these blood pressure readings or documentation of interventions made at this time. The treatment flow sheet revealed on 11/8/23 at 7:48 a.m., Patient #6’s BP was 195/94 at the onset of dialysis treatment. The treatment nurse assessment entered on 11/8/23 at 7:49 a.m. revealed her pre-treatment standing blood pressure was 193/103 and her pre-treatment sitting blood pressure was 212/94. At 8:00 a.m., 12 minutes after dialysis started, her BP had decreased to 174/66. A review of the medical record did not reveal evidence the nurse or physician was notified of these blood pressure readings or documentation of interventions made at this time. This was in contrast to the Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment policy which read, if an abnormal finding was reported to the nurse pre-treatment, the nurse assessed the patient prior to the initiation of dialysis. The nurse used his/her clinical judgment based on individual patient needs to determine if any clinical interventions were necessary. This was also in contrast to the Patient Parameters provided by the facility which read, intradialytic parameters reportable to the charge nurse included systolic blood pressure over 180. ii. A review of medical records revealed Patients #6, #2, and #5 experienced fluctuations in blood pressure with changes greater than 20 points with no evidence that the results were reported to the floor nurses or documented per facility policy. Examples included: a. A review was conducted of Patient #6’s medical record. The treatment flow sheet revealed on 10/27/23 at 9:00 a.m., Patient #6’s BP was 158/76, and at 9:30 a.m., had increased to 180/65, a 22-point increase over 30 minutes. On 11/13/23 at 7:51 a.m., Patient #6’s BP was 159/74, and at 8:01 a.m., the BP increased to 182/87, a 23-point increase over 10 minutes. b. A review was conducted of Patient #2’s medical record. The treatment flow sheet revealed on 11/2/23 at 3:00 p.m., Patient #2’s BP was 102/43, and at 3:31 p.m., the BP increased to 146/40, a 44-point increase over 31 minutes. On 11/4/23 at 2:29 p.m., Patient #2’s BP was 123/71, and at 3:00 p.m., the BP increased to 147/79, a 24-point increase over 31 minutes. On 11/11/23 at 1:31 p.m., Patient #2’s BP was 126/73, and at 2:01 p.m., the BP decreased to 97/59, a 29-point decrease over 30 minutes. c. A review was conducted of Patient #5’s medical record. The treatment flow sheet revealed on 10/31/23 at 9:31 a.m., Patient #5’s BP was 126/57, and at 10:01 a.m., the BP decreased to 104/57, a 22-point decrease over 30 minutes. On 11/4/23 at 7:31 a.m., Patient #5’s BP was 173/72, and at 8:01 a.m., the BP decreased to 150/63, a 23-point decrease in 30 minutes. On 11/4/23 at 9:01 a.m., Patient #5’s BP was 110/53, and at 9:31 a.m., the BP increased to 144/72, a 34-point increase in 30 minutes. This was in contrast to the Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment policy which read, during intradialytic data collection/assessment, abnormal findings were reported to the nurse immediately. All findings, interventions and patient response were documented in the patient’s medical record. The following was considered an abnormal finding and was reported to the nurse: intradialytic BP difference of 20 point increase or decrease from the patient’s last intradialytic treatment BP reading. Members of the patient care team reported any changes in patient conditions or concerns of patient well-being immediately to the nurse at any time. B. Interviews i. An interview was conducted on 11/15/23 at 12:37 p.m. with patient care technician (PCT) #6. PCT #6 stated she and the other PCTs notified the nurses when a patient’s blood pressure was out of parameters, including changes in BP trends, and documented this assessment and notification of the RN. She stated the RN followed behind the PCT and documented their assessment and intervention as well. PCT #6 stated this process was important so the RN could notify the physician of changes in patients’ medical condition in order to ensure patient safety. ii. An interview was conducted on 11/15/23 at 1:15 p.m. with infection control RN #4. RN #4 stated she was confident the PCTs monitored blood pressure trends as they were in constant communication with her. However, RN #4 stated if the PCTs did not document the RN notification, it would appear the RN was not notified. She stated the nurses had 30 minutes to enter the pre-treatment assessment in the electronic health record after dialysis was initiated and there was no way to document when the assessment was actually performed. She stated there was a risk to the patient in not following this process. iii. An interview was conducted on 11/15/23 at 2:06 p.m. with the facility administrator (FA) #1. FA #1 stated proper documentation by staff members was not currently a quality project, however, she had discussed the importance of correct documentation with staff during team meetings. FA #1 stated if PCTs did not notify the RN of changes in blood pressure, the RN would not know how the patient was trending during dialysis treatments. She stated if these notifications were not documented, the PCT could not prove they notified the RNs. FA #1 stated the risk of not notifying the RNs of changes in blood pressure was that the patient could have negative consequences on dialysis treatment, such as elevated blood pressure leading to a stroke (a loss of blood supply to part of the brain). She stated for Patient #6, her expectation was to see documentation the physician was notified and interventions made for the patient as a result. FA #1 stated the risk to the patient with a blood pressure in the 200s/90s was the patient having medical issues while on treatment which could have led to a stroke and the need for medical care outside the facility. She stated there was no way to discern if the pre-treatment nursing assessment was completed pre- or post-dialysis initiation however, ideally, a patient was assessed when entering into the facility or before being started on dialysis.”

“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: 47962 Based on document review and interviews, the facility failed to ensure staff demonstrated competencies necessary to sustain the skills needed to perform the specific duties of their positions in two of 13 personnel files reviewed. Findings include: Facility policy: According to the Teammate Qualifications, Licensure, and Adequate Teammate Staffing policy, the dialysis facility’s teammates (or contractors) will meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. 1. The facility failed to ensure staff competencies were maintained to sustain the skills needed to perform the specific duties of their positions. a. Review of ESRD Core Survey Facility Worksheet: Personnel File documentation provided by the facility revealed staff competencies were expired. Examples included: i. Competencies for social worker (SW) #7 were completed on 4/12/22. ii. Competencies for registered dietician (RD) #8 were completed on 5/13/22. iii. Upon request, the facility was unable to provide evidence of completed competencies prior to the start of the survey on 11/13/23. These examples were in contrast to the Teammate Qualifications, Licensure and Adequate Teammate Staffing policy which read, the dialysis facility’s teammates (or contractors) would meet the demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. b. On 11/15/23 at 2:06 p.m., an interview was conducted with facility administrator (FA) #1. FA #1 stated SW #7 and RD #8 were overdue on their competencies. FA #1 stated competencies were due annually. Additionally, FA #1 stated it was important for competencies to be completed annually to ensure staff performed their job duties appropriately. FA #1 stated if competencies were not maintained, there was a risk staff would not follow current practices when care was provided to patients.”

“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: 47962 Based on interviews and document review, the facility failed to ensure one of three new hemodialysis (a treatment that filters the blood with a machine and a filter) patients received a nursing evaluation prior to the initiation of dialysis. Findings include: Reference: According to the New Patient Pre-Treatment Evaluation policy, all new patients are to be evaluated by a registered nurse (RN) prior to the initiation of their first treatment at the facility. The RN as required by federal regulation will perform an initial pre-treatment evaluation for all new patients prior to the initiation of their first treatment at the facility. According to the Patient Rights policy, patients have the right to receive adequate and safe dialysis treatment by competent personnel and patients have the right to be informed about and participate, if desired in all aspects of the individualized plan of care. 1. The facility failed to ensure a new patient received an initial pre-treatment evaluation by an RN prior to the initiation of the first treatment at the facility. A. Document review i. Medical record review revealed Patient #1 began hemodialysis treatment on 10/18/23. There was no evidence in the medical record of a new patient evaluation by an RN. Upon request, the facility could not provide an initial nursing patient assessment for Patient #1. This was in contrast to the New Patient Pre-Treatment Evaluation policy that read, all new patients were to be evaluated by an RN prior to the initiation of their first treatment at the facility. B. Interview i. On 11/15/23 at 2:06 p.m., an interview was conducted with registered nurse and facility administrator (FA) #1. FA #1 stated Patient #1 must not have received an initial nursing assessment prior to his first dialysis treatment at the facility as she could not find the evaluation in Patient #1’s medical record. She stated conducting and documenting the initial nursing evaluation was important in order to establish a baseline of health for the patient prior to starting dialysis. She stated this baseline was important in case the patient had an emergent health issue such as severe fluid overload or difficulty breathing that would require the patient to be sent to the emergency room or be addressed by the physician prior to initiating dialysis.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 47962 Based on observations, interviews, and document review, the facility failed to ensure medical records in the peritoneal dialysis (PD) (a treatment that uses the lining of the abdomen to filter a person’s blood) nurse room were stored securely to prevent unauthorized access. This failure affected all 11 of the PD medical records stored at the facility. Findings include: Facility policy: According to the Medical Records Custodian and Maintenance policy, the purpose is to verify that medical records are maintained in proper order with current information and retained in a manner that meets federal and state regulations while facilitating patient care. At the discretion of the facility administrator, the nurse responsible for clinical care and/or designee is responsible for the supervision and authenticity of medical records services. The responsibilities of the custodian of medical records include verifying that the medical records are complete, documented accurately, and maintained in accordance with accepted professional standards and practices and additionally, safeguards the confidentiality of the medical record in accordance with established policy and legal requirements. According to the Patient Rights policy, patients are entitled to be fully informed of the right to privacy and confidentiality in all aspects of treatment and to know their medical records and the information contained will be considered private and confidential and only released in compliance with state and federal law. 1. The facility failed to ensure the medical records of patients receiving peritoneal dialysis were stored in such a manner as to prevent unauthorized access. A. Observations i. Observations conducted in the PD nurse room on 11/14/23 at 1:38 p.m. revealed 11 medical records stored in an unlocked cabinet above the nurse’s desk. Observations also revealed the room itself was not able to be locked. This observation was in contrast to the Medical Records Custodian and Maintenance policy which read the purpose was to verify that medical records were retained in a manner that met federal and state regulations. The responsibilities of the custodian of medical records included verifying that the medical records were safeguarded in order to maintain the confidentiality of the medical record. This was also in contrast to the Patient Rights policy which read, patients were entitled to know their medical records and the information contained were considered private and confidential. a. Follow-up observations conducted in the PD nurse room on 11/14/23 at 4:01 p.m. revealed the cabinets were now locked. B. Document review i. A review of a medical record stored in the PD nurse room revealed the name of the patient, his medical record number, dates and times of his visits, lab values, and various types of education provided to him by the PD nurse. C. Interviews i. An interview was conducted on 11/14/23 at 1:27 p.m. with registered nurse (RN) #2. RN #2 stated medical records for the PD patients were kept in an unlocked cabinet above her desk. She stated the door to the PD nurse room was not ever locked. RN #2 stated the risk of not securing medical records was that people without the proper authorization could access patients’ medical information, violating their right to privacy. This interview was in contrast to the Medical Records Custodian and Maintenance policy which read the medical records were safeguarded in order to maintain the confidentiality of the medical record. This was also in contrast to the Patient Rights policy which read, patients were entitled to know their medical records and the information contained was considered private and confidential. ii. An interview was conducted on 11/15/23 at 1:15 p.m. with infection control RN #4. RN #4 stated staff secured all medical records for patient privacy. She stated this was especially important in a smaller community where everyone knew each other. iii. An interview was conducted on 11/14/23 at 1:56 p.m. with facility administrator (FA) #1. FA #1 stated the cabinets in the PD nurse room were supposed to be kept locked. She stated housekeeping cleaned the facility in the evenings when facility staff were not present. FA #1 stated storing medical records in a way that prevented unauthorized access was important to protect patients’ medical information. She stated she had found the key to the cabinets and moving forwards the records would be kept in a locked location at all times.”

“GOV-GB INFORMS MED STAFF OF P&P/QAPI PROG CFR(s): 494.180(c)(2),(3) The governing body- (2) Ensures that all medical staff who provide care in the facility are informed of all facility policies and procedures, including the facility’s quality assessment and performance improvement program specified in §494.110. (3) Communicates expectations to the medical staff regarding staff participation in improving the quality of medical care provided to facility patients. This Standard is not met as evidenced by: 47962 Based on interviews and document review, the facility failed to ensure facility policies were updated and easily accessible to staff. Additionally, the facility failed to ensure the medical staff met regularly and maintained written records of their meetings. Findings include: Facility policies: According to the General Statement on Clinical Policies, the purpose is to define the process for developing and implementing policies and procedures (P&P). Clinical policies and procedures are developed in accordance with federal regulations. Clinical policies and procedures are expected to be adequate, accurate, and up-to-date. Approved clinical policies and procedures are to be approved by the Facility Governing Body prior to implementation with approval documented in Governing Body meeting minutes. All policies and procedures are reviewed on an ongoing basis as regulations change, equipment and technology advance, medical knowledge expands, and upon continuous evaluation of patient safety and quality of care. The facility’s Governing Body is responsible for implementation of all policies and procedures. According to Definitions: Policy, Procedure, Protocols, Order, and Clinical Pathway, policies were located on the company’s P&P website with a single sign-on required. Reference: The Medical Staff Bylaws read, each facility’s medical staff shall hold staff meetings as needed to address patient care needs of the facility or more frequent meetings as required by state or local law. 1. The facility failed to ensure policies were updated and easily accessible to staff. A. Document review i. On 11/14/23 at 2:24 p.m. upon a request to review the facility’s policies, the facility administrator (FA) #1 provided the surveyor with policies from a binder stored in the conference room. Policies in the binder included the Patient Assessment and Plan of Care policy, revised in March of 2013. FA #1 stated there was an updated assessment policy but this had not yet been approved by the medical director (Director) #5, so the March 2013 policy was still in place. FA #1 also provided the Intradialytic Treatment Monitoring policy, revised in March of 2012, then later stated there was a newer policy available and provided the Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment policy, revised in April of 2017. ii. A further review of facility policies in the binder revealed other policies were not uniformly reviewed, updated, and available to the staff. Examples included: a. Infection Control for Dialysis Facilities, revised April 2019 b. Medical Records Custodian and Maintenance, revised October 2019 c. Medical Record Maintenance, revised March 2011 The document review was in contrast to the General Statement on Clinical Policies which read, clinical policies and procedures were expected to be adequate, accurate, and up-to-date. All policies and procedures were reviewed on an ongoing basis. This was also in contrast to According to Definitions: Policy, Procedure, Protocols, Order, and Clinical Pathway which read, policies were located on a website. B. Interviews i. An interview was conducted on 11/15/23 at 3:56 p.m. with patient care technician (PCT) #10. PCT #10 stated she accessed facility policies on the company’s website. She stated the only policy difference between this facility and other facilities under the same company had to do with facility-specific blood pressure parameters. This interview was in contrast to the binder provided by FA #1 when asked to review facility policies. ii. An interview was conducted on 11/15/23 at 3:57 p.m. with PCT #9. PCT #9 stated she accessed policies on the company website as this is where updated and approved policies were located. This interview was in contrast to the binder provided by FA #1 when asked to review facility policies. iii. An interview was conducted on 11/15/23 at 3:58 p.m. with registered nurse (RN) #4. RN #4 stated she accessed policies on the company’s website however, she stated the online policies were not reflective of the policies actually used at this facility. RN #4 stated in order to know if a policy was approved for this facility, staff had to look in both the binder and the online resource. She stated the risk of having different policies between facilities, as well as using policies which had not been updated, was a lack of awareness of which policies were approved for current use in the facility. iv. Interviews were conducted on 11/14/23 at 2:24 p.m. and 11/16/23 at 7:49 a.m. with FA #1. FA #1 stated policy revisions were approved by Director #5. She stated there was not a schedule by which Director #5 reviewed and approved policies. FA #1 stated some of the policies used by the facility were current company-wide policies that had also been approved by Director #5 and other policies were specific only to the facility as potential updates were awaiting his approval. FA #1 stated approved facility-specific policies and procedures were kept in a binder in the conference room. She stated the PCTs also worked at other facilities and needed to know which policies were approved company-wide and which policies were accessible on the company website, even if those same policies were not in use at this facility. FA #1 also stated the company-wide policies may not have reflected the policies Director #5 had approved for use at this facility. FA #1 stated the risk of having policies that were not updated and different than policies at other company facilities, with her staff potentially not being aware of those policy differences or how to access facility-specific policies, was a negative outcome for a patient if the wrong procedure or policy was followed. v. An interview was conducted on 11/15/23 at 10:06 a.m. with clinical manager (Manager) #11. Manager #11 stated Director #5 had approved the facility policies currently in use in 2019. She stated policies requiring further updates were with Director #5 awaiting his approval. Manager #11 stated if there was a policy that could critically affect patient care, Director #5 would sign off on that policy more quickly. These interviews were in contrast to the General Statement on Clinical Policies which read, clinical policies and procedures were expected to be adequate, accurate, and up-to-date. All policies and procedures were reviewed on an ongoing basis. The interviews were also in contrast to According to Definitions: Policy, Procedure, Protocols, Order, and Clinical Pathway which read, policies were located on a website. 2. The facility failed to ensure the medical staff met regularly and maintained written records of those meetings. A. Document review i. Upon request, the facility was unable to provide documentation of medical staff meetings and minutes from those meetings. This was in contrast to the Medical Staff Bylaws which read, each facility’s medical staff held staff meetings to address patient care needs of the facility as required by state or local law. B. Interviews i. On 11/15/23 at 3:02 p.m., an interview was conducted with nurse practitioner (NP) #3. NP #3 stated the facility did not have medical staff meetings. She stated she communicated with the providers from her own provider group in lieu of meetings with the facility’s entire medical staff to discuss patient care. ii. On 11/15/23 at 7:09 a.m., an interview was conducted with FA #1. FA #1 stated the providers did not have medical staff meetings. FA #1 stated medical staff meetings were important to keep the medical staff on the same page and to maintain continuity of care. iii. On 11/14/23 at 12:52 p.m., an interview was conducted with medical director (Director) #5. Director #5 stated the facility did not hold medical staff meetings. He stated politics between the provider groups and the facility deterred closer communication among the medical staff. Director #5 also stated the lack of medical staff meetings to discuss patient care was not a risk to providing safe patient care. This was in contrast to the Medical Staff Bylaws which read, each facility’s medical staff held staff meetings to address patient care needs of the facility as required by state or local law.”