Davita Gonzales Dialysis Center

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 34839 Based on patient record reviews, review of the facility’s policy, and staff interviews it was determined the facility failed to ensure direct patient care staff reported significant changes in the patients’ health status while receiving hemodialysis to the registered nurse (RN) and/or the charge nurse (CN); and the RN and/or the CN failed to complete further patient assessments, interventions, and physician notifications when significant changes occurred during treatment in accordance with the facility’s policy; “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” and State law that indicates a RN shall conduct a patient assessment when indicated by a question relating to a change in the patient’s status for 2 of 2 patients reviewed (Patient #1 and Patient #2). Specifically, Patient #1 and Patient #2’s records documented critically abnormal vital signs that were outside of the facility’s set policy parameters and documented changes of patient status without documentation that the RN and/or CN was notified; and the RN and/or CN failed to conduct patient assessments to determine if clinical interventions or notification of physician was necessary. As a result, Patient #1 became nonresponsive, Emergency Medical Services were activated, and patient was transferred to a local hospital emergency room. This deficient practice had the likelihood to cause harm and delay in care to all in-center hemodialysis patients receiving care at the facility. The cumulative effect of these deficient practices resulted in the facility’s inability to meet the Condition for Coverage: Patient Assessment Refer to tag: V 504 for specific findings.”

“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: 34839 Based on patient record reviews, review of the facility’s policy, and staff interviews it was determined the facility failed to ensure direct patient care staff reported significant changes in the patients’ health status while receiving hemodialysis to the registered nurse (RN) and/or the charge nurse (CN); and the RN and/or the CN failed to complete further assessments, interventions, and physician notifications when significant changes occurred during treatment in accordance with the facility’s policy; “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” and State law that indicates a RN shall conduct a patient assessment when indicated by a question relating to a change in the patient’s status for 2 of 2 patients reviewed (Patient #1 and Patient #2). Specifically, Patient #1 and Patient #2’s records documented critically abnormal vital signs that were outside of the facility’s set policy parameters and documented changes of patient status without documentation that the RN and/or CN was notified; and the RN and/or CN failed to conduct patient assessments to determine if clinical interventions or notification of physician was necessary. As a result, Patient #1 became nonresponsive, Emergency Medical Services were activated, and patient was transferred to a local hospital emergency room. This deficient practice had the likelihood to cause harm and delay in care to all in-center hemodialysis patients receiving care at the facility. The findings included: Review of the facility’s policy: 1-03-08, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised April 2024 indicated the following, in part; POLICY: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes but is not necessarily limited to: i. Measurement of patient temperature ii. Measurement of Blood Pressure (BP) 1. Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in the patient electronic record or flow sheet) 2. Intradialytic BP in the sitting/reclined or supine position iii. Heart or pulse rate, noting also if the beat is regular or irregular iv. Patient weight v. Patient’s report of well-being, level of pain or discomfort, complaints, hospitalization vi. Vascular access status 2. The Nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) or if performance of a nursing assessment is permitted by state law, a Licensed Practical Nurse (LPN) / Licensed Vocational Nurse (LVN). a. The assessment includes the following components: vi. A physical assessment of the patient which includes 1. Apical heart rate and rhythm 2. Auscultation of the lungs 3. Evaluation of volume status including edema 4. Bruising or bleeding 5. Patient statement of well-being, level of pain or discomfort 6. And other components which if observed/informed will be documented, including but not necessarily limited to the following: o Change in normal level of consciousness, mobility or mental status o Complaint of nausea, vomiting, diarrhea, constipation, skin changes, headache, respiratory distress, angina, weakness, fever, cramping, dizziness o Reports of illness and/or injuries, falls, conditions/complications or other problem patient has experienced since the last dialysis treatment INTRADIALYTIC DATA COLLECTION/ASSESSMENT 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record. ABNORMAL FINDINGS, Page 5 Blood Pressures: Pre Dialysis- Systolic greater than 180 mm/Hg or less than 90 mm/Hg. Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Intra Dialysis - Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Post Dialysis- Standing or Sitting: Systolic greater than 140 mm/Hg or less than 90 mm/Hg Standing or Sitting: Diastolic greater than or equal to 90 mm/Hg or less than 50 mm/Hg Hear or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heartbeat. Pre/Intra/Post Patient Reports/ Complaints and/or teammate observation of; in part: o Pain, chest pain o New onset of rash, skin lesions, ulcers or change in skin color, new bruising or cuts o Weakness or numbness o Cramping o Changes in mobility, ambulation, or reports of falls o Changes in level of consciousness, ability to communicate Observation conducted in the facility’s treatment area on 3/3/25 at 12:30 PM revealed a typed paper that was posted on a wall at a workstation used by facility staff that indicated the following, in part: “Parameters to Report to CN [Charge Nurse].” 1. Gain > kg. Weight < EDW or previous post weight. 2. Post wt 1 kg< or > EDW 3. Temp 100 or> Chills or fever during treatment 4. Apical HR <55 or > 110 or irregular any changes from baseline 5 Resp < 12 or > 28 breaths per minute, labored apnea orthopnea or change from baseline 6. BP_ Pre- systolic >180 <100 - Diastolic: 110 or > Intra_ systolic >180 or <100 - Diastolic: 90 or > Post _ systolic >180 or <100 - Diastolic: 90 & > or <60 7. Confusion, lethargy, non-responsive, any change from baseline 8. New S&S medical dental or surgical procedures, diagnostic test, injuries, falls or bleeding 1.) Patient # 1 Records reviewed: Review of Patient #1’s hemodialysis flow sheets, titled “Treatment Details Report” dated 12/3/24 revealed the following, in part: Pre-Vitals: 122/79 heart rate 62. Initiation of treatment: 09:38 AM The Following vitals were documented: 09:38 AM: Blood Pressure: 149/57 with heart rate 55 by Licensed Vocational Nurse (LVN) #6. 09:42 AM: Blood Pressure: 53/23 with heart rate 58 by LVN #6: Further review revealed Patient #1’s record did not contain documentation LVN #6 notified the RN of the abnormal critical hypotension. 09:46 Blood Pressure 81/38 pulse 60, UF (ultrafiltration) off, patient alert documented by LVN #6. There was not any documentation the RN was notified of the abnormal critical hypotension. 09:50 AM: Blood Pressure 105/54 Pulse 56 by LVN #6. There was not any documentation the RN was notified of the abnormal diastolic hypotension and abnormal pulse rate below 60. 10:17 AM: blood pressure 149/57 Pulse 55 by LVN #6. There was not any documentation the RN was notified of the abnormal diastolic hypotension and abnormal pulse rate below 60. 10:11 AM: Blood pressure 133/62 Pulse 56 by LVN #6. There was not any documentation the RN was notified of the abnormal pulse rate below 60. 10:21 AM: Blood pressure 102/50 Pulse 45 Documented UF off by LVN #1. There was not any documentation the RN was notified of the abnormal diastolic hypotension and abnormal pulse rate below 60. 10:31 AM Blood Pressure 125/52 Pulse 54 Documented UF resumed by LVN #6. There was not any documentation the RN was notified of the abnormal diastolic hypotension and abnormal pulse rate below 60. 10:41 AM Blood Pressure 111/51 Pulse 55 by LVN #6. There was not any documentation the RN was notified of the abnormal diastolic hypotension and abnormal pulse rate below 60. 10:51 AM Blood Pressure 107/49 Pulse 56 Documented UF off by LVN #6. There was not any documentation the RN was notified of the abnormal diastolic hypotension and abnormal pulse rate below 60. 11:01 AM Blood pressure 106/51 Pulse 59 Documented UF remains off by LVN #6. There was not any documentation the RN was notified of the abnormal diastolic hypotension and abnormal pulse rate below 60. 11:11 AM Blood Pressure 87/47 Pulse 58 Documented UF off by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension and abnormal pulse rate below 60. 14:23 (2:23 PM) Updated by LVN #6 “ PT [Patient] asymptomatic” 11:21 AM Blood pressure 73/35 Pulse 60 Documented retaking BP by LVN #6. There was not any documentation the RN was notified of the abnormal critical hypotension. 11:24 AM Blood pressure 92/48 Pulse 66 Documented UF remains off by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension. 11:30 AM Blood Pressure 102/48 Pulse 57 Documented Patient awake: alert: and states no complaints at this time by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension and abnormal pulse rate below 60. 11:41 AM Blood Pressure 113/50 Pulse 60 Documented UF resumed by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension. 11:50 AM Blood Pressure 97/84 Pulse 85 Documented UF off by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension. 12:02 PM Blood Pressure 100/35 Pulse 60 Documented patient monitored eyes closed: Patient resting. by LVN #6. There was not any documentation the RN was notified of the abnormal critical diastolic hypotension. 12:11 PM Blood Pressure 98/51 Pulse 61 Documented UF remains Off patient alert. by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension. 12:22 PM Blood Pressure 88/42 Pulse 59 Documented BP dropped : UF remains off by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension and abnormal pulse rate below 60. 12:31 PM Blood Pressure 82/40 Pulse 61 Documented UF remains off patient asymptomatic by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension. 12:41 PM Blood Pressure 81/42 Pulse 57 Documented UF remains off: pt watching TV by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension and abnormal pulse rate below 60. 12:50 PM Blood Pressure 82/39 Pulse 59 Documented patient states no complaints at this time: UF remains off Pt denies feeling bad by LVN #6. There was not any documentation the RN was notified of the abnormal critical diastolic hypotension and abnormal pulse rate below 60. 13:01 PM Blood Pressure 75/41 Pulse 57 Documented 100 ml of Normal Saline (NS) given by LVN #6. There was not any documentation the RN was notified of the abnormal critical diastolic hypotension and abnormal pulse rate below 60. 13:10 PM Blood Pressure 91/58 Pulse 49 Documented BP improved UF remains off by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension and abnormal pulse rate below 60. 13:13 PM Blood pressure 125/53 Pulse 58 Documented came to chairside to check on patient she was leaning forward in the chair when asked if she was ok no response was given laid patient back administered 200 ml normal saline while retaking blood pressure by LVN #6. There was not any documentation the RN was notified of the abnormal diastolic hypotension and abnormal pulse rate below 60. 13:57 PM updated : Patient leaning forward in chair ; when asked if she was ok no response was given; laid patient back and administered 200 ml normal saline while retaking blood pressure by LVN #6. 13:16 PM Blood pressure 96/74 Pulse 114 (abnormally high) by LVN #6. Documented Called charge nurse [#7] to chair side patient was not responding O2 applied via nasal cannula liters “BG [sic] was 119.” 14:18 PM Updated: rinse back started treatment terminated documented by LVN #6. 13:17 PM Blood Pressure 75/65 Pulse 58 Documented 200 ml NS given Blood pressure dropped by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension and abnormal pulse rate below 60. 13:19 PM Blood Pressure 87/57 Pulse 62 Documented B/P improving by LVN #6. There was not any documentation the RN was notified of the abnormal hypotension. 13:23 PM Blood Pressure 117/65 Pulse 55 by Charge Nurse #7 Documented patient placed on pulse oximeter O2 sat range from 95% to 100% via 2 liter nasal cannula; bradycardia noted on pulse ox of 39. 13:28 PM Blood Pressure 130/56 Pulse 56 by LVN #6 Documented blood returned, Charge Nurse at chair side. Patient #1’s record revealed there had not been any notifications to a physician or a non-physician practitioner (NPP) by a licensed nurse for the change in Patient #1’s status (non-responsive), abnormal and critical vitals that were documented at the initiation of treatment at 09:38AM to 13:28 (1:28 PM). Patient #1’s record did not include an RN or CN assessment for the change in Patient #1’s abnormal and critical vitals that were documented by the LVN at the initiation of treatment at 09:38 AM and throughout treatment until 13:23 (1:23 PM), when CN #7 documented Patient #1’s vital signs and that patient was placed on O2, via 2 liter nasal cannula. Bradycardia noted. 13:31 PM Blood Pressure 126/66 Pulse 62 by CN #7 Documented 911 called for unresponsive patient; patients daughter notified of occurrence; NP [NPP] notified of pending EMS (Emergency Medical Services) transport. Further review of the Treatment Details report documented a post dialysis weight of 74.8 kilograms. Patient #1 became nonresponsive during treatment and was waiting for EMS transfer post dialysis. Review of the facility incident report form dated 12/10/24 completed by Staff #2 indicated Patient #1 was transferred on 12/3/24 to a hospital during treatment due to symptomatic hypotension during treatment leading to unresponsiveness near end of treatment. EMS took patient to local emergency department. Further review of the facility incident report documented the following actions to be taken to reduce the potential of similar incidents; in part: “Will notify MD [Medical Doctor] earlier in treatment when pt [patient] hypotensive.” Action included, Education of staff. 2.) Patient # 2 Records reviewed: Review of Patient #2’s hemodialysis flow sheets, titled “Treatment Details Report” dated 3/1/25 revealed the following, in part: Initiation of treatment: 05:13 AM Termination of treatment: 09:18 AM. Pre-Vitals: 103/55 heart rate 71. RN #7 Pre Treatment Assessment at 05:21AM documented, “Patient presents with large raised bruise on the left side of head in the forehead area. He also has a blackened eye with significant edam [sic] present. Patient reports falling at the SNF [skilled nursing facility] a “ a few days ago.” While wheeling the patient to the treatment chair. The patient, without warning or instruction, placed he right foot down and his toes we bumped by the wheelchair. No evidence of a wound was initially present following this event. Patient is somewhat agitated this morning, but is following requests to safely begin treatment. Tylenol provided for chronic pain. BP low, but patient is stable to start treatment.” The Following vitals were recorded: 05:13 AM: Blood Pressure: 128/64 with heart rate 58. The Patient Care Technician (PCT) #4 documented the following “treatments without complications; normal saline was given; heparin infusion stared. There was not any documentation the RN was notified of the abnormal pulse rate below 60. 05:31 AM Blood Pressure 98/50 Pulse 67 the PCT #4 Documented Patient access cannulated without difficulty. There was not any documentation the RN was notified of the abnormal blood pressure (hypotension) and abnormal pulse rate below 60. 06:01 AM Blood Pressure 115/58 Pulse 68 the PCT #4 Documented Patient awake; alert ; and states no complaints at this time. There was not any documentation the RN was notified of the abnormal diastolic hypotension. 06:31 AM Blood Pressure 92/56 Pulse 69 the PCT #4 Documented Patient appears to be tolerating treatment well at this time. There was not any documentation the RN was notified of the hypotension. 07:01 AM Blood pressure 47/30 Pulse 73 the PCT #4 Documented retaking BP. There was not any documentation the RN was notified of the abnormal critical hypotension. 07:03 AM Blood pressure 155/143 Pulse 65 the PCT #4 Documented retaking BP. There was not any documentation the RN was notified of the abnormal critical hypertension (high blood pressure parameters). 07:04 AM Blood Pressure 146/117 Pulse 79 the PCT #4 Documented retaking BP. There was not any documentation the RN was notified of the abnormal critical hypertension (high blood pressure parameters). 07:05 AM Blood Pressure 111/41 Pulse 71 the PCT #4 Documented patient cramping UF off. There was not any documentation the RN was notified of the abnormal hypotension or that the RN directed the UF off. 07:16 AM Blood Pressure 103/54 Pulse 59 RN#7 Documented drop in BP noted; patient remains stable. 07:31 AM Blood Pressure 45/23 Pulse 56 the PCT #4 Documented retaking BP. There was not any documentation the RN was notified of the abnormal critical hypotension or the abnormal pulse rate. 07:32 AM Blood Pressure 90/47 Pulse 65 the PCT #4 Documented UF off patient resting. There was not any documentation the RN was notified of the abnormal hypotension. 07:46 AM Blood Pressure 69/27 Pulse 67 the PCT #4 Documented retaking BP. There was not any documentation the RN was notified of the abnormal critical hypotension. 07:47 AM Blood Pressure 76/35 Pulse 44 the PCT #4 Documented retaking BP readjusted cuff. There was not any documentation the RN was notified of the abnormal critical hypotension or the abnormal pulse rate. 07:49 AM Blood Pressure 86/43 Pulse 68 the PCT #4 Documented UF off no complaints There was not any documentation the RN was notified of the abnormal hypotension. 08:00 Am Blood Pressure 103/68 Pulse 90 the PCT #4 Documented patient awake; alert; and states no complaints at this time. 08:16 AM Blood pressure 46/20 Pulse 57 the PCT #4 Documented retaking BP. There was not any documentation the RN was notified of the abnormal critical hypotension or the abnormal pulse rate. 08:18 AM Blood Pressure 96/53 Pulse 67 the PCT #4 Documented UF remains off. There was not any documentation the RN was notified of the abnormal hypotension. 08:46 AM Blood Pressure 98/50 Pulse 68 RN #7 Documented UF on; patient stable with no symptoms; monitoring. 09:01 AM Blood Pressure 86/40 Pulse 66 the PCT #4 Documented patient states no complaints at this time; UF off. There was not any documentation the RN was notified of the abnormal hypotension. 09:14 AM Blood Pressure 94/42 Pulse 60 the PCT #4 Documented retaking BP. There was not any documentation the RN was notified of the abnormal hypotension. 09:16 AM Blood Pressure 75/46 Pulse 56 the PCT #4 Documented retaking BP. There was not any documentation the RN was notified of the abnormal hypotension or abnormal pulse rate. 09:18 AM Blood Pressure 85/39 Pulse 65 the PCT #4 Documented Treatment terminated. There was not any documentation the RN was notified of the critical abnormal hypotension. Post Vitals: 98/52 heart rate 62 at 09:24 AM. Further review of the Treatment Details report and the facility’s Electronic Medical Record for Patient #2 revealed there had not been any notifications to a physician or a NPP by a licensed nurse for the change in Patient #2’s status for abnormal and critical vitals that were documented. In addition, there was not any evidence a physician or NPP was notified that Patient #2 presented with observed head injuries from a reported fall in which 4100 units of heparin was administered throughout treatment without physician consultation, or the incident where Patient #2’ foot and toes were bumped by the wheelchair. Interview with Charge Nurse (CN) Staff #3 on 3/3/25 at 12:34 PM stated the following: Upon review of Patient #2’s Electronic Medical Record confirmed there had not been any notifications to a physician or a NPP by a licensed nurse for the change in Patient #2’s status for abnormal and critical vitals that were documented on 3/1/25. In addition, there was not any evidence a physician or NPP was notified that Patient #2 presented with observed head injuries from a reported fall in which 4100 units of heparin was administered throughout treatment without physician consultation, or the incident where Patient #2’ foot and toes were bumped by the wheelchair. CN #3 stated patients with a head injury would require the physician to be notified. In addition, “That big of a drop [Blood Pressure], yes” would require physician notification. Interview with the Facility Administrator (FA) on 3/3/205 at 12:14 PM was asked by the surveyor who conducts the quality reviews for the patients flowsheet audits. The FA stated, “It’s month to month. We go over the findings with the team. We determine that by the month I print it out and [Staff #2] does the analysis of it.” The FA indicated that nursing staff is to “call right away [the physician] if there’s an issue.” The FA confirmed the PCT should document in the patients records, the notification to the RN of abnormal vital parameters or change in patient status; and the RN should document the follow up assessment in the patients records after report by the PCT. The FA stated at 12:50 PM “He [CN #7] needs to be documenting his actions. That needs to be addressed.” Further interview with the FA at 1:09 PM was asked by the surveyors for the Inservice provided to the facility staff as documented on the Facility incident report form dated 12/10/24. The FA responded, “I’m looking for that, I don’t see it.” The FA was made aware by the surveyors, that upon review of Patient #2’s Treatment Details Report dated 3/1/25, facility staff continue to not report abnormal parameters to an RN and the Physician is not notified when there is a change in patient status. FA responded, “Correct. That’s what we need to define. The parameters.” Interview with Staff #2 on 3/3/25 at 1:22 PM was asked by the surveyors for the Inservice provided to the facility staff as documented on the Facility incident report form dated 12/10/24. Staff #2 stated “No, where does it say that.” Surveyors read directly from the facility incident report form dated 12/10/24, “Actions Taken, Education off staff” “Yeah, that’s for me. Sounds like I need a homeroom.” Staff #2 confirmed there had not been an Inservice presented to the facility staff in response to this hospital transfer. Texas Administrative Code, Title 25, Part 1, Chapter 117, Provision and Coordination of Treatment and Services Rule §117.45(d)(8): (d) Nursing services. (8) A licensed nurse or dialysis technician shall collect and document objective and subjective data for each patient before and after treatment according to facility policy and the staff member’s level of training. There shall be written policies and procedures specific to the facility to guide actions to be taken by the nursing staff in the event a patient’s condition deteriorates during treatment, to identify parameters which would require a patient be referred to a nurse for evaluation. A registered nurse shall conduct a patient assessment when indicated by a question relating to a change in the patient’s status or at the patient’s request.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 39425 Based on facility policy and staff interview, the facility’s social worker had a patient load of 226+ patients, which exceeds licensed social worker limit per the State guidelines. State guidelines are 1 social worker to 100 patients with up to 125 patients with clerical support. Findings included: Policy: Teammate Qualifications, Licensure and Adequate Teammate Staffing #8-02-01 Revision Date October 2017 Policy reads in part: 1. This is a general policy based on the CMS Conditions for Coverage. State regulations, if applicable, will supersede this general policy. Interview with Facility Administrator on 9/9/2024 from 1016 to 1018 was asked by surveyors if the facility had a permanent social worker, the Facility Administrator responded “No.” The surveyors continued by asking if the facility had an open requisition for a social worker and the Facility Administrator stated “Yes, I’ve heard they are interviewing for it.” Surveyors also asked how long the facility has not had a permanent social worker, the Facility Administrator stated “Long time. About 2 years.” Surveyors asked if the social worker is part of the Interdisciplinary Team (IDT) meetings, the Facility Administrator stated “No, she doesn’t sit in on our IDT meetings.” The Facility Administrator went on to state “I wish I had one, it would make things a lot smoother.” Interview with the Social Worker via telephone on 9/9/2024 from 1020 to 1024 confirmed that the Social Worker has the responsibility of approximately 226 patients working between 3 different dialysis facilities. Interview with Regional Operations Director on 9/9/2024 at 1140 stated “I realize we’ve been operating out of social worker parameters. We’ll get a contract worker in place immediately.””