Pediatric Dialysis Unit at UCSF

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 43380 Based on record review and interview, the facility failed to maintain the written emergency preparedness plan (EPP). This was evidenced by including accurate emergency strategy information. This affected five of five patients and could result in confusion during a power outage. Findings: During record review and interview with regulatory staff and Engineering staff on 11/18/25, the EPP was reviewed. At 2:44 p.m., the facility’s EPP titled, “UCSF Health, Environment of Care (EOC) Manual” was reviewed. The section for “Utility emergencies” on page 20 indicated “Red power outlets are connected to the hospital’s emergency generators and will remain active during power outages.” There were no red electrical outlets observed in the dialysis suite, and all electrical outlets and cover plates were white. Upon interview, Regulatory Staff 1 stated that the EOC manual was used for multiple University of San Francisco Medical Center campuses and acknowledged that this may cause confusion with staff during a power outage.”

“Fire Alarm System - Testing and Maintenance CFR(s): NFPA 101 Fire Alarm Systems - Testing and Maintenance A fire alarm system is tested and maintained in accordance with an approved program complying with the requirements of NFPA 70, National Electric Code, and NFPA 72, National Fire Alarm and Signaling Code. Records of system acceptance, maintenance and testing are readily available. 9.6.1.3, 9.6.1.5, NFPA 70, NFPA 72 This Standard is not met as evidenced by: 43380 Based on record review and interview, the facility failed to maintain the fire alarm system (FAS). This was evidenced by the failure to provide semiannual FAS battery test documentation. This affected five of five patients and could result in the delay of notification to emergency forces in the event of an emergency. NFPA 101: Life Safety Code, 2012 Edition - 21.3.4 Detection, Alarm, and Communications Systems. 21.3.4.1 General. Ambulatory health care facilities shall be provided with fire alarm systems in accordance with Section 9.6, except as modified by 21.3.4.2 through 21.3.4.4. 9.6.1.3 A fire alarm system required for life safety shall be installed, tested, and maintained in accordance with the applicable requirements of NFPA 70, National Electrical Code, and NFPA 72, National Fire Alarm and Signaling Code, unless it is an approved existing installation, which shall be permitted to be continued in use. NFPA 72: National Fire Alarm and Signaling Code, 2010 Edition Chapter 14 Inspection, Testing, and Maintenance 14.1 Application. 14.1.1 The inspection, testing, and maintenance of systems, their initiating devices, and notification appliances shall comply with the requirements of this chapter. 14.4.5* Testing Frequency. Unless otherwise permitted by other sections of this Code, testing shall be performed in accordance with the schedules in Table 14.4.5, or more often if required by the authority having jurisdiction. Table 14.4.5 Testing Frequencies. 6. Batteries-fire alarm systems (d) Sealed lead-acid type (1) Charger test: Annually (2) Discharge test (30 minutes): Annually (3) Load voltage test: Semiannually 14.6.2 Maintenance, Inspection, and Testing Records. 14.6.2.1 Records shall be retained until the next test and for 1 year thereafter. 14.6.2.4 * A record of all inspections, testing, and maintenance shall be provided that includes the following information regarding tests and all the applicable information requested in Figure 14.6.2.4: (1) Date (2) Test frequency (3) Name of property (4) Address (5) Name of person performing inspection, maintenance, tests, or combination thereof, and affiliation, business address, and telephone number (6) Name, address, and representative of approving agency(ies) (7) Designation of the detector(s) tested (8) Functional test of detectors (9)* Functional test of required sequence of operations (10) Check of all smoke detectors (11) Loop resistance for all fixed-temperature, line-type heat detectors (12) Functional test of mass notification system control units (13) Functional test of signal transmission to mass notification systems (14) Functional test of ability of mass notification system to silence fire alarm notification appliances (15) Tests of intelligibility of mass notification system speakers (16) Other tests as required by the equipment manufacturer’s published instructions (17) Other tests as required by the authority having jurisdiction (18) Signatures of tester and approved authority representative (19) Disposition of problems identified during test (e.g., system owner notified, problem corrected/successfully retested, device abandoned in place) Findings: During record review and interview with Engineering Staff on 11/18/25, the FAS inspection and testing records were reviewed. 1. At 1:44 p.m., the facility failed to provide documentation that 2 of 2 semiannual load voltage tests had been conducted on the batteries in the fire alarm control panel (FACP). The semi-annual fire alarm system inspection and annual fire alarm system test were conducted on a monthly basis. Upon interview, Engineering Staff 1 stated that the batteries were replaced every three years, and they would have to contact their vendor for the FACP battery testing records. The facility was given until 10:00 a.m. on 11/19/25 to provide the FACP battery load voltage test records to the California Department of Public Health (CDPH). As of 11/19/25, CDPH did not receive the records from the facility. 2. At 1:47 p.m., the facility failed to provide documentation that the annual 30 minute discharge test was conducted on the FACP batteries within the last 12 months. The semi-annual fire alarm inspection system and annual fire alarm system test were conducted on a monthly basis. Upon interview, Engineering Staff 1 stated that the batteries were replaced every three years, and they would have to contact their vendor for the FACP battery testing records. The facility was given until 10:00 a.m. on 11/19/25 to provide the FACP battery test records to the California Department of Public Health (CDPH). As of 11/19/25, CDPH did not receive the records from the facility. 3. At 1:48 p.m., the facility failed to provide documentation that the annual charger test was conducted on the FACP batteries within the last 12 months. The semi-annual fire alarm inspection system and annual fire alarm system test were conducted on a monthly basis. Upon interview, Engineering Staff 1 stated that the batteries were replaced every three years, and they would have to contact their vendor for the FACP battery testing records. The facility was given until 10:00 a.m. on 11/19/25 to provide the FACP battery test records to the California Department of Public Health (CDPH). As of 11/19/25, CDPH did not receive the records from the facility.”

“Fire Drills CFR(s): NFPA 101 Fire Drills Fire drills include the transmission of a fire alarm signal and simulation of emergency fire conditions. Fire drills are held at expected and unexpected times under varying conditions, at least quarterly on each shift The staff is familiar with procedures and is aware that drills are part of established routine. Where drills are conducted between 9:00 PM and 6:00 AM, a coded announcement may be used instead of audible alarms. 21.7.1.4 through 21.7.1.7 This Standard is not met as evidenced by: 43380 Based on record review and interview, the facility failed to ensure that all staff were familiar with the fire drill procedures. This was evidenced by missing fire drills records. This affected five of five patients and could result in staff being untrained and unaware of their roles and responsibilities in the event of a fire. Findings: During record review and interview with fire prevention staff on 11/19/25, the fire drill records were requested. At 1:05 p.m., the facility failed to provide documentation that fire drills were conducted during first quarter (January, February, March) Second quarter (April, May, June) and third quarter (July, August, September) of 2025. The last fire drill record available for review was dated 10/22/24. Upon interview, Fire Prevention Staff 1 stated that he thought fire drills were required annually.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 38066 Based on observation, interview, and record review, the facility failed to implement processes to manage medical and non-medical emergencies when the emergency evacuation kit did not contain: 1. 3-cc syringes, and 2. first aid kit This failure may pose a significant health and safety risk to the patients, especially during public health emergencies or natural disasters when dialysis facilities may be disrupted. Findings: Review of facility document titled “Pediatric Dialysis Unit-Emergency Kit Checklist” for the year 2025, indicated, “ ...Item ...3 cc syringe 20 ea (each) ...First Aid Kit 2 ea ...” both marked with an “x”. During an inspection on 9/23/25 starting at A10:35 AM with Registered Nurse (RN) 2, the following items were observed missing in the emergency evacuation kit: a. 20 pieces 3-cc syringe b. two first aid kits During a concurrent interview, RN 2 confirmed the observation. During an interview on 9/23/25 at 1:46 PM, RN 3 stated the facility had no policy on emergency equipment and supplies.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 38066 Based on observation, interview, and record review, the facility failed to ensure the safety of two of eight patients (Patient 4 and Random Patient 8) when their vascular access (patient’s lifeline which makes life-saving hemodialysis treatments possible) site during treatment was covered and not in staff’s view. This failure placed patients at risk for line disconnection to go undetected, which poses risks for extensive loss of blood due to bleeding. Findings: 1. During a concurrent observation and interview on 9/23/25 at 10:24 AM with Registered Nurse (RN) 1, Random Patient (RP) 8 was in a chair on Bay 5, receiving hemodialysis (HD - a treatment that removes waste products and excess fluid from the blood when the kidneys are unable to do so) and part of the patient’s blanket was on top of his chest covering the access. When asked if RP 8’s access was visible, RN 1stated, “No it’s not.” RN 1 then pulled the blanket to expose access and stated, RP 8’s access was a right central venous catheter (CVC - a thin, flexible tube inserted into a large vein in the chest used for hemodialysis). RN 1 further stated the access should always be visible to know “what’s going on, if there’s bleeding or dislodgement.” 2. During a concurrent observation and interview on 9/23/25 at 10:27 AM with RN 1, Patient 4 was in a chair on Bay 3, receiving HD and the patient’s shirt was covering the access. RN 1 acknowledged that Patient 4’s access was covered, then proceeded to pull up part of patient’s shirt to expose access, which was a CVC, and stated, “it should be like this” (access should be visible). During an interview with patient, Patient 4 stated he didn’t know “why it (access) has to be visible.” During an interview on 9/23/25 at 1:46 PM, with RN 3, RN 3 stated the expectation was “access is visible at all times.” Review of facility’s policy and procedure titled, “Intradialytic Monitoring Dialysis Specific Procedure”, last reviewed/revised 06/2019, indicated, “ ...Critical Points ...3. All patients and their access sites must be visible to staff at all times during the dialysis treatment ...Patient and Access Monitoring ...2. Access sites must be visible at all times during the treatment unless developmental status makes this a safety issue ...””

“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: 38066 Based on interview and record review, the facility failed to ensure accurate comprehensive assessments and management of blood pressure (BP - the force of blood pushing against the walls of your arteries as your heart pumps it through your body) and fluid for one of seven sampled patients (Patient 3) when there was no documentation of patient’s assessment and intervention by the Registered Nurse (RN) when Patient 3 had low BP during dialysis treatment. This failure had the potential for unsafe fluid removal and/or blood pressure changes that posed a risk for severe adverse consequences, including but not limited to, dizziness, fainting spells which may lead to serious harm or death. Findings: During a concurrent interview and record review on 9/25/25 at 8:53 AM with RN 2, Patient 3’s post treatment sheets, dated 9/15/25 and 9/17/25 were reviewed. The post treatment sheet dated 9/15/25 indicated Patient 3’s BP was 121/77 at 8:28 AM when treatment was initiated. At 10:30 AM, patient’s BP dropped to 98/66, Patient Care Technician’s (PCT) documentation indicated, “pt sleeping”. At 10:45 AM, patient’s BP further dropped to 91/59, with no documentation by PCT. At 11:16 AM, Patient 3’s BP was 94/57, PCT documented “BP low UF (ultrafiltration - a process that removes excess fluid from the blood during dialysis) will remain off until improve”. From 10:30 AM until end of dialysis treatment at 11:46 AM, Patient 3 had fluctuating low systolic blood pressure (SBP - the top number in a BP reading and measures the pressure when your heart muscle is squeezing and pumping blood out to the body). The post treatment sheet dated 9/17/25 indicated Patient 3’s BP was 114/74 at 8:14 AM when treatment was initiated. At 10:15 AM, patient’s BP dropped to 98/69. At 10:30 AM, patient’s BP further dropped to 96/63, PCT’s documentation indicated, “pt alert”. At 11:30 AM, patient’s BP was 93/59 and the UF was off with no documentation by PCT. From 10:15 AM until end of dialysis treatment at 11:53 AM, Patient 3 had trending low SBP. Patient 3’s standing BP post-treatment was 99/55. For post treatment sheets dated 9/15/25 and 9/17/25, there was no documentation that the PCT had informed the RN of the drop in patient’s BP and turning off the UF. On both post treatment sheets, RN 2 acknowledged there was no documented evidence of RN assessment addressing Patient 3’s low BP, and stated, “None.” Review of Patient 3’s dialysis prescription indicated, “ ...Goal SBP>: 100 ...” Review of facility’s policy and procedure titled, “”Intradialytic Monitoring Dialysis Specific Procedure” last reviewed/revised 06/2019, indicated, “ ...Critical Points ...5. Any deviation from the prescribed dialysis prescription must be documented and reported to the RN ...Vital Sign Monitoring ...5. The RN must be notified of any BP’s outside of these parameters ...Hypotension ...Systolic blood pressure less tehn [sic] prescribed minimum for patient ...4. Intervention ...b. Notify RN. Stop ultrafiltration and ensure patient’s feed [sic] are elevated ...””

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 38066 Based on interview and record review, the facility failed to ensure the physician’s hemodialysis prescription was implemented for one of seven sampled patients (Patient 4) when the dialysate flow rate (DFR - important parameter that affect the cleaning of the blood of toxins) was not followed for Patient 4. This deficient practice placed the patient at risk of not receiving adequate dialysis treatments that would meet their individual needs. Findings: During a review of Patient 4’s clinical record, two post treatment sheets dated 9/17/25 and 9/20/25, indicated the physician ordered DFR was 600 ml/min. Patient 4 has a central venous catheter (CVC - a thin, flexible tube inserted into a large vein in the chest used for hemodialysis) as access. Review of the following Post Treatment Sheets indicated: On 9/17/25, on initiation of treatment at 8:00 AM, DFR was set at 600 ml/min. At 8:35 AM, DFR was set at 500 ml/min. Then, from 9:00 AM to termination of treatment, DFR was lowered to 400 ml/min. Patient Care Technician (PCT) did not notify the Registered Nurse (RN) about the change in DFR. RN had no documentation of actions taken to address the change in DFR. On 9/20/25, DFR was set at 400 ml/min for almost an hour, from start of treatment at 7:38 AM to 8:30 AM. PCT did not notify the RN about the change in DFR. RN had no documentation of actions taken to address the change in DFR. During a concurrent interview and record review on 9/25/25 at 10:03 AM with RN 2, Patient 4’s post treatment sheets, dated 9/17/25 and 9/20/25 were reviewed. RN 2 stated the RN verifies the physician’s orders against what is set on the machine at the start of dialysis treatment. RN 2 acknowledged that the DFR was not set according to physician’s order and stated, “DFR was not as ordered and there was no documentation for the change.” Review of facility’s policy and procedure titled, “Intradialytic Monitoring Dialysis Specific Procedure” last reviewed/revised 06/2019, indicated, “ ...Dialysis Machine Monitoring 1. The dialysis machine settings should be checked by an RN within the first 30 minutes of treatment for accuracy of the ordered prescription. 2. Any change in BFR/DFR should be reported to the RN and documented in the EMR ...””