Davita Texarkana Regional Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48653 Based on observation, policy review, and staff interview, the facility staff failed to A. follow their policies regarding personal protective equipment and hand hygiene. The staff failed to follow the facility’s policy titled, “ Infection Control for Dialysis Facilities.” (Cross Refer to Tag V0113) B. ensure all sinks used for hand washing by the patients and staff had warm water available. (Cross Refer to Tag V0114) C. ensure direct-care staff were competent in the facility’s process for changing wet external transducers. The staff failed to follow the facility’s policy titled, “CHANGING TRANSDUCER PROTECTORS”. (Cross Refer to Tag V0120) D. clean and disinfect all contaminated surfaces and equipment in the patient treatment area. The staff failed to follow the facility’s policy titled, “ Infection Control for Dialysis Facilities.” (Cross Refer to Tag V0122)”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 48653 Based on observation, record review and interview, A. the Registered Nurse failed to provide oversight and direction to the direct patient care staff to ensure that the patient’s prescribed dose of dialysis was correct. Prescription settings checked in the last hour of treatment revealed 3 (#15, #18, #34) out of 3 machines were not running at the physician’s prescribed orders for temperature and BFR (blood flow rate). The facility staff failed to follow facility policy, “Pre-Intra-Post Data Collection, Monitoring, and Nursing Assessment”. (Cross Refer to Tag V0503) B. the nursing staff failed to evaluate the appropriateness of the dialysis prescription by failing to complete a post-dialysis assessment. The nursing service also failed to assess the patient when significant changes occurred during treatment and report significant blood pressure and heart rate changes to the attending physician. (Cross Refer to Tag V0504)”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 30377 Based on observation, policy review, and staff interview, the facility staff failed to follow their policies regarding personal protective equipment and hand hygiene. The staff failed to follow the facility’s policy titled, “ Infection Control for Dialysis Facilities.” These findings have the likelihood to cause cross-contamination and increase the chance of infection to all patients and staff within the facility. Findings included: During observation of the dialysis treatment room floor on 02/05/24 and 02/06/24, the following infection control issues were observed: On 02/05/24 at 1:16 PM Staff # 22 was observed terminating the Hemodialysis dialysis session. Staff #22 was gloved when observed assisting the patient to a sitting position by pushing down the dialysis chair footrest. Staff # 22 then proceeded to remove the tape from the access arm and remove the dialysis needles. Staff # 22 did not change gloves or use hand sanitizer after touching the footrest before moving to the access arm to remove the needles. On 2/5/24 at 1:22 PM Staff Member 19 was observed terminating the Hemodialysis dialysis session. The following tasks were observed with Staff Member 19 not changing gloves or hand sanitizing between the following tasks: -Silencing machine alarms, moving rolling stool, assisting the patient to a sitting position by pushing down the dialysis chair footrest, moving the rolling computer, removing tape from the access arm, handling clean gauze, and removing the dialysis needles. On 2/6/23 at 10:53 AM Staff # 12 was observed conducting a pre-dialysis assessment including raising the patient’s pant leg with no gloves on. No hand hygiene was completed before moving to the computer cart. On 2/6/23 at 11:05 AM Staff Member 12 was observed conducting a pre-dialysis assessment with no gloves on. No hand hygiene was completed before moving to the computer cart. A review of the facility policy titled; “Infection Control for Dialysis Facilities 1-05-01, “ revealed the following: “All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene prior to gloving and immediately after removal of gloves, after patient and dialysis delivery system contact, between patients even if the contact is casual, before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station, this will include patients and visitors assisting with procedures such as self-cannulation or holding access sites. Gloves should be changed when: When going from a “dirty” area or task to a “clean” area or task, When moving from a contaminated body site to a clean body site of the same patient; and After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system.” An interview with Staff #1 and Staff #14 on 2/5/2024 at 1:45 PM confirmed that the staff members had failed to change gloves and hand sanitize between tasks as directed by facility policy.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 50181 Based on observation, policy review, and staff interview, the facility failed to ensure all sinks used for hand washing by the patients and staff had warm water available. Findings include: During observations of the treatment floor on February 5, 2024 at 1:30 PM observed that the sink nearest the medication preparation area did not get warm when the surveyor attempted to wash her hands for greater than 30 seconds prior to exiting the treatment floor. A review of facility policy tiled, “INFECTION CONTROL FOR DIALYSIS FACILITIES” with a revision date of April 2023 revealed the following: “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. POLICY: The Centers for Disease Control (CDC) Recommendations for preventing transmission of infections among Chronic Hemodialysis Patients will be followed when caring for all patients ... 19. Sinks should be easily accessible and readily available in treatment area and in other appropriate areas such as medication area, home training room, and isolation area/room. a. Sinks must be plumbed with both hot and cold water. b. Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place. c. Soap and a supply of paper towels protected from contamination must be available at each clean sink...” An interview with Staff # 14 on 02/05/2024 at 1:45 PM confirmed there were sinks on the treatment floor with no warm water.”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 29191 Based on observation, policy review, and staff interviews, the facility failed to ensure direct-care staff were competent in the facility’s process for changing wet external transducers. The staff failed to follow the facility’s policy titled, “CHANGING TRANSDUCER PROTECTORS”. This deficient practice had the likelihood to result in harm to all patients receiving care at the facility by introducing patient blood into the dialysis machine. This could cause contamination of the dialysis machine and allow other patients to become exposed to blood contamination. Findings include: During a tour of the facility’s in-center treatment area on 02/05/2024 at 12:32 PM with Staff #3, the surveyor observed Staff #25 caring for the patient at station #32. The surveyor noticed the hub of the external transducer on the machine at station #32 was wet with blood. When questioned regarding the process for recognizing and changing the external transducer, Staff #25 stated, “ I know to change the transducer if there is blood in it.” The machine had a broken part that was covering the transducer and the flip lid would not stay up for complete visibility of the transducer. The flip lid had a piece of paper tape on it to help keep the lid up. Paper tape can not be disinfected from blood splatter that might occur during the treatment. Staff #25 proceeded to change the wet transducer but did not check the back of the transducer to notice if blood had been introduced into the machine. Staff #25 did not state the appropriate process for inspecting the back of the external transducer and what should occur if the back of the external transducer became contaminated with blood or saline. A review of the facility’s policy titled, “CHANGING TRANSDUCER PROTECTORS” dated April 2021, revealed the following: “PURPOSE: To provide guidance for changing transducer protectors and preventing cross-contamination. POLICY: 1. This policy is intended for all dialysis delivery systems that utilize blood tubing sets with external pressure transducer protectors in the arterial and venous pressure monitoring system. 2. During intradialytic treatment monitoring, the arterial and venous drip chamber levels should be observed and adjusted as needed. 3. External transducer protectors will be inspected for the presence of blood or saline every 30 minutes during patient treatment and included as part of the monitoring process. 4. The external transducer protector will be replaced: Prior to each patient’s use and whenever blood or saline is observed in contact with the patient side of the transducer protector. 5. If the external transducer protector becomes contaminated with blood or saline, the teammate will replace the external transducer protector and adjust the arterial and/or venous drip chamber as needed. After adjusting the arterial and/or venous drip chamber levels the patient’s arterial and venous pressures should be compared to previous treatment readings ... 7. The back of the wet external transducer protector and the delivery system pressure module luer locks will be visually inspected for blood or saline contamination prior to placing the new sterile external transducer protector on the delivery system. If blood or saline is noted on the back of the wet external transducer protector, strikethrough has occurred. The treatment can continue for this patient on this delivery system if accurate pressures are observed. Upon completion of treatment, the delivery system is to be removed from service and labeled with the date, time, description of the problem, and the name of the teammate reporting the problem ...” An interview with Staff #3 on 02/05/2024 at 12:45 PM confirmed that Staff #25 did not follow the facility’s policy for inspecting and changing the external transducers on the dialysis machines.”

“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: 30377 Based on observation, policy review, and staff interview, the facility staff failed to clean and disinfect all contaminated surfaces and equipment in the patient treatment area. The staff failed to follow the facility’s policy titled, “ Infection Control for Dialysis Facilities.” Findings included: A tour of the facility on 02/05/24 at 12: 35 PM revealed the following : * Dust buildup on computer chairs at the workstation in the dialysis treatment area. * Dust buildup under the countertops at the workstation in the dialysis treatment area. * Patient’s wheelchairs/walkers were stored alongside used biohazard containers in the treatment area. * The isolation room (last used on 02/03/24) had debris on the floor and trash in the trash can indicating the room had not been cleaned at the end of the day by the cleaning crew on 02/03/2024 and/or 02/04/2024. * There were 3 of 3 dialysis chairs inspected that had grim build-up on the metal aspect of the chair. Observed dried brown stains that appeared to be dry blood splatter on the side and cushion of one of the three chairs. These dialysis chairs had been designated as “clean.” During a tour of the dialysis treatment room floor on 02/05/24 and 02/06/24 at 1:30 PM the following was observed: Staff #19, #22, and #25 were observed cleaning and disinfecting the dialysis station after treatments. Staff #19, #22, and #25 did not fully recline the patient treatment chair to ensure all crevices were thoroughly cleaned. The metal aspect of the dialysis chair was not cleaned observed dust and dirt. The same staff members did not clean/disinfect the television surface, the computer cart, and or the emergency take-off kit at each station. A review of the facility policy titled, “Infection Control for Dialysis Facilities Policy 1-05-01” states in part “Disinfection: At the end of each treatment, the dialysis station will be cleaned and disinfected. Surfaces to disinfect include but are not necessarily limited to all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front, and sides of a dialysis machine; touchscreens; countertops). An Interview with Staff #1 and Staff # 4 on 02/05/2024 at 1:35 PM confirmed the facility staff were not disinfecting the dialysis stations per the facility policy.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 48653 Based on record review and staff interviews, the facility’s biomedical and direct care staff failed to recognize and correct out-of-parameter results obtained during bicarbonate conductivity testing. This deficient practice had the likelihood to cause harm to all patients receiving hemodialysis at the facility due to the potential for patients to be exposed to a bicarbonate solution that did not meet conductivity parameters. Exposure to improper concentrations of bicarbonate solution could harm all patients receiving hemodialysis at the facility. A review of the facility’s document titled, “Bicarb Mix Log- Conductivity with Myron L 4P or 6P” revealed the following, “Bicarbonate Mixing Tank Conductivity Test Result Parameters: 48-52 mS” “Bicarbonate Return Loop Conductivity Test Result Parameters: 48-52 mS” “50 mS Standard Solution Test Result Parameters: 49.5-50.5mS” On 11/22/2023 at 4:30 AM, Staff # 12 documented a bicarbonate mixing tank conductivity test result of “47.2mS” and a bicarbonate return loop conductivity test result of “47.2mS”. The bicarbonate mix solution did not meet the conductivity parameters. There is no documentation supporting the disposal of this batch of bicarbonate. On 12/11/2023 at 04:45 AM, Staff # 19 documented a 50mS Standard Solution Test Result of “49.2mS”. The conductivity meter did not pass the parameters to ensure proper machine calibration. There was no documentation to support the conductivity machine (Myron Meter) being recalibrated before the testing of the bicarbonate solution. On 01/05/2024 at 5:04 AM, Staff # 7 documented a 50mS Standard Solution Test Result of “49.0mS”. The conductivity meter did not pass the parameters to ensure proper machine calibration. There was no documentation to support the conductivity machine (Myron Meter) being recalibrated before the testing of the bicarbonate solution. On 01/06/2024 at 04:56 AM, Staff # 7 documented a 50mS Standard Solution Test Result of “49.0mS”. The conductivity meter did not pass the parameters to ensure proper machine calibration. There was no documentation to support the conductivity machine (Myron Meter) being recalibrated before the testing of the bicarbonate solution. On 01/13/2024 at 04:30 AM, Staff # 12 documented a 50mS Standard Solution Test Result of “50.8mS”. The conductivity meter did not pass the parameters to ensure proper machine calibration. There was no documentation to support the conductivity machine (Myron Meter) being recalibrated before the testing of the bicarbonate solution. On 01/24/2024 at 04:45 AM, Staff # 19 documented a 50mS Standard Solution Test Result of “50.6mS”. The conductivity meter did not pass the parameters to ensure proper machine calibration. There was no documentation to support the conductivity machine (Myron Meter) being recalibrated before the testing of the bicarbonate solution. A review of the facility’s document titled, “Calibration Log for Myron L Ultra meter 4P” revealed the following, “Meter Value Parameters: 49.5-50.5” On 12/14/2023, Staff # 19 documented a Meter Value result of “49.4”. Staff # 19 did not recognize an out-of-parameter meter value and failed to re-calibrate the conductivity machine when it was required. On 01/06/2024, Staff # 17 documented a Meter Value result of “49.0”. Staff # 17 did not recognize an out-of-parameter meter value and failed to re-calibrate the conductivity machine when it was required. On 01/24/2024, Staff # 19 documented a Meter Value result of “50.6”. Staff # 19 did not recognize an out-of-parameter meter value and failed to re-calibrate the conductivity machine when it was required. A review of the facility policy titled, “Bicarbonate Conductivity Batch Testing” with a revision date of April 2017 revealed the following, “PURPOSE: To provide guidance for bicarb concentrate conductivity batch testing. POLICY: 1. Facility specific bicarbonate batch conductivity test procedures will be developed and written by the Biomed team, in conjunction with the Facility Administrator. They are to be reviewed and approved by the Group Biomed Manager (GBM) and/or Biomed Operations Manager (BOM) and validated prior to implementation. These procedures are reviewed and approved by the Governing Body of the facility prior to implementation. 2. The meter used for this procedure is dedicated to bicarb concentrate conductivity batch mixing. The approved meters are the Phoenix Meter or Myron L 4P/6P. Proportioned dialysate bicarb and bicarb concentrate have different ranges. The meter has to be standardized with a standard solution for the range anticipated for the solution to be tested. If facilities elect to use conductivity batch testing as an additional qualification test, teammates will follow this policy as outlined. 3. Water used for bicarb mixing meets DaVita standards for dialysis quality water. 4. Bicarb conductivity batch testing is performed to verify final bicarb concentrate quality of each batch prepared. This policy and the facility specific procedure do not replace final independent pH and conductivity dialysate safety checks performed at the patient station prior to treatment initiation. 5. Bicarb concentrate mix preparation is performed in accordance with manufacturers’ directions for use. 6. For central delivery bicarb systems, two (2) collection sample sites must be identified and labeled as follows: a. The first site is the outlet of the mixing tank prior to entry into the distribution system. b. The second site is the return to the end of the distribution loop where it enters the distribution tank. 7. For non-central bicarb systems, one (1) sample site must be identified and labeled. This sample site is the final bicarb mix, an example would be the jug dispense site. 8. The meter will be maintained per the manufacturer’s recommendations. *Prior to testing bicarb conductivity, confirm the meter calibration with a 50mS conductivity standard solution. The results should be: *Myron L 4P/6P - 49.5mS-50.5mS and are to be documented on Bicarb Mix Log-Conductivity utilizing a Myron L 4P/6P *Phoenix Meter - 48mS-52mS and are to be documented on Bicarb Mix Log-Conductivity utilizing a Phoenix Meter *50 mS solution is utilized to verify meter accuracy within specified test range for bicarb concentrate. If calibration of the meter is not within acceptable range, contact Biomed. 9. The bicarb concentrate conductivity reading should be within acceptable range. *Acceptable conductivity range is 48 - 52 mS 10. If test results are acceptable, bicarb concentrate is ready for distribution. 11. If results are unacceptable, re-test. If second result is unacceptable, discard bicarb concentrate batch. Unacceptable test results indicate bicarb concentrate is improperly mixed and batch should be discarded.” In an interview with Staff # 2 and # 17 on 02/06/2024 at 12:45 PM, Staff # 2 stated, “I did not recognize that ranges were being documented that were out of parameter. I review the logs every month and did not notice the discrepancy.” Staff # 17 stated, “I don’t know what happened that day. I usually pay very close attention to the results I document to make sure they meet the parameters.””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 30377 Based on observation, record review and interview, the Registered Nurse failed to provide oversight and direction to the direct patient care staff to ensure that the patient’s prescribed dose of dialysis was correct. Prescription settings checked in the last hour of treatment revealed 3 (#15, #18, #34) out of 3 machines were not running at the physician’s prescribed orders for temperature and BFR (blood flow rate). The facility staff failed to follow facility policy, “Pre-Intra-Post Data Collection, Monitoring, and Nursing Assessment”. Findings included: Observation of the treatment floor on 02/05/24 at 1:05 PM revealed the following discrepancies during machine setting verification. Machine 15: The physician’s hemodialysis orders stated BFR setting at 450 and temperature at 37.0 degrees celcius. Review of the dialysis machine setting revealed the BFR at 400 and the machine temperature was set at 36.0 degrees celcius. Machine 18: The physician’s hemodialysis orders stated temperature setting at 37.0 degrees celcius. Review of the dialysis machine setting revealed the temperature was set at 35.5 degrees celcius. Machine 34: The physician’s hemodialysis orders stated the temperature setting at 37.0 degrees celcius. Review of the dialysis machine setting revealed the temperature was set at 36.0 degrees celcius. A review of the facility policy titled, “Pre-Intra-Post Treatment Data Collection” with a revision date of October 2023 revealed the following: “PURPOSE: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patientâ Euro (Trademark)s dialysis treatment, monitoring during treatment and for reviewing the patients response to the treatment and status prior to discharge... 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings j. Heparinization (intradialytic infusion setting)” An interview conducted with Staff Member #3 on 02/05/2024 at 1:10 PM confirmed the discrepancies with the machine settings.”

“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: 30377 Based on observation, record review, and staff interview, the nursing staff failed to complete a post-dialysis assessment. The nursing service also failed to assess the patient when significant changes occurred during treatment and report significant blood pressure and heart rate changes to the attending physician. The findings included: Observations on 02/05/2024 and 02/06/2024 revealed multiple patients walking unattended to the scale, recording their post weight. The patients were observed leaving the facility without a staff member ensuring appropriate post-weight was obtained. There was no post-assessment completed by an RN during the observations. Patient # 8 Treatment Sheet dated 01/29/24: Pre-Dialysis Blood Pressure documented at 1:19 PM by the patient care technician staff # 26 was 244/134. No documentation was found that the RN staff # 27 was notified of the severe hypertension. The dialysis treatment was initiated via the central venous catheter at 2:07 PM by the RN staff # 27. The blood pressure at the initiation of treatment was documented at 225/124. No documentation was found to support that the physician was notified of severe hypertension before the start of hemodialysis treatment. At 5:19 PM the RN staff # 27 documented “Hypertension still noted: 0.1mg of PRN Clonidine given, Patient states she feels warm temperature turned down. Will continue to monitor patient.” The blood pressure at that time was recorded as 195/145. The following blood pressures were recorded after the Clonidine was administered: Blood Pressure documented at 5:31 PM by the patient care technician staff # 26 was 205/130 . Blood Pressure documented at 6:02 PM by the patient care technician staff # 26 was 214/140. Blood Pressure documented at 6:31 PM by the patient care technician staff # 26 was 241/111. Blood Pressure documented at 6:40 PM by the patient care technician staff # 26 was 218/132. A review of the facility’s standing order for Clonidine administration is as follows: “Clonidine 0,1mg P.O administered for Systolic > 190 or diastolic > 100 may repeat x 1 after one hour if still above parameters. Notify MD if BP is still elevated 30 minutes after the second dose.” Second Clonidine was not given or documented as refused when the first dose was not effective per the standing order. MD was not notified when Clonidine was not effective per standing order. There was no documentation to support that the MD was not notified of severe hypertension and the patient was discharged with a blood pressure of 218/132. Treatment was initiated at 2:07 PM with an RN prescription check documented at 4:42 PM. The RN staff # 27 did not verify that the patient was receiving the correct prescription, as ordered by the physician within the first hour of treatment. BFR (Blood Flow Rate) was prescribed at 350 with the machine set at 400 at initiation of treatment with no documentation by the direct patient care tech staff # 26 or RN staff # 27 to explain the discrepancy. Treatment Sheet dated 01/31/24: Pre-Dialysis Blood Pressure documented at 5:16 PM by the patient care technician staff # 26 was 256/143. There was no documentation that supported the RN staff # 16 was notified of the severe hypertension. The dialysis treatment was initiated via the central venous catheter (CVC) at 5:29 PM by the RN staff # 16. The blood pressure at the initiation of treatment was documented at 264/149. At 5:35 PM the RN staff # 16 documented a blood pressure of 256/133. No documentation was found that supported the physician was notified of the severe hypertension prior to the start of hemodialysis. The following blood pressures were recorded after Clonidine was administered: Blood Pressure documented at 6:01 PM by the patient care technician staff # 26 was 268/137. Blood Pressure documented at 6:31 PM by the patient care technician staff # 26 was 261/136. Blood Pressure documented at 6:33 PM by the patient care technician staff # 26 was 267/133. Blood Pressure documented at 6:37 PM by the patient care technician staff # 26 was 268/130 Blood Pressure documented at 6:51 PM by the registered nurse staff # 16 was 262/136. Blood Pressure documented at 7:01 PM by the patient care technician staff # 26 was 257/127. Blood Pressure documented at 7:32 PM by the patient care technician staff # 26 was 264/117. Blood Pressure documented at 7:56 PM by the patient care technician staff # 26 was 267/119. Blood Pressure documented at 8:01 PM by the patient care technician staff # 26 was 264/132 There was no documentation to support the MD was notified when Clonidine was not effective per standing order. There was no documentation to support the MD was notified of severe hypertension and the patient was discharged with a blood pressure of 264/132. Patient # 11 Flow Sheet dated 01/23/24: Treatment was initiated at 11:30 AM by the patient care technician staff # 25. Blood Pressure 95/62 with a heart rate of 65. At 1:24 PM Blood Pressure was 67/51 with a heart rate of 74. At 1:25 PM Blood Pressure was 89/66 with a heart rate of 44. At 1:27 PM Blood Pressure was 93/71 with a heart rate of 46. At 1:30 PM Blood Pressure was 117/62 with heart rate 51. The bradycardia was not reported or addressed by the RN staff # 28. There was no documentation found that supported the MD was notified of the bradycardia and the symptomatic hypotension during treatment. An interview conducted with Staff #1 and Staff # 21 on 02/06/24 at 12:30 PM confirmed the flow sheet findings. Staff # 1 stated, “I was unaware of discrepancies found on the flow sheets.” Staff # 21 stated, “Charge RNs do not always have time to complete post-assessments.””

“QAPI-QAPI-IMMEDIATELY CORRECT ANY IJ ISSUES CFR(s): 494.110(c) The facility must immediately correct any identified problems that threaten the health and safety of patients. This Standard is not met as evidenced by: 50181 Based on observation and staff interview, the facility failed to recognize and immediately correct deficient practices that threaten the safety of the patients. The facility’s leadership and quality program failed to recognize and immediately correct unsafe practices of direct care staff. The direct care staff were observed altering and bypassing the air detector alarm on the hemodialysis machine while the patient was undergoing treatment. This deficient practice had the likelihood causing harm to the dialysis patients by manually by-passing the air detector alarm increases the risk of an air embolism. Findings include : Observed on 2/05/2024 at 1:30 PM, Staff #8, manually by-passed the air detector alarm on machine #16, during a patient’s 1:30 PM treatment, by pressing the metal lever on the machine that allows the machine to detect air and alert the staff with an audible alarm. Staff member #8 confirmed the action during an interview and stated, “I do that to fill the chamber when the air detector alarm goes off.” This observation was reported to staff member #14. A review of the the manufacturer guidelines in the 2008K Hemodialysis Machine Operator’s Manual (Rev P, page 147) revealed the following related to the air detector alarm, “Purpose of the alarm: The level of the blood in the venous drip chamber is too low. Actions: 1) Inspect the venous drip chamber and level detector module to see if: *There is an adequate level of blood (approximately ¾ full) in the chamber. *The venous drip chamber is properly mounted in its holder. *The venous drip chamber is positioned with the mesh filter below the level detection sensors. *The sensors are clean (if not clean, clean with an alcohol pad). *The level detector door is closed and latched. 1) Raise the blood level by pressing and holding the up key on the level detector until the chamber is approximately ¾ full. 2) Press the RESET key to reset the alarm. If unable to reset the alarm, return the blood to the patient and take the machine out of service. Have a qualified technician recalibrate for the type of bloodline used. Warning! Ensure the air will not be infused into the patient when the blood flow is re-established.” An interview with Staff #14 on 2/5/2024 at 1:35 PM confirmed staff were manually by-passing the air detector alarm on machine.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 29191 Based on observation, record review, and interview, the facility failed to: A. monitor and provide a sanitary environment to minimize the transmission of infectious agents within the dialysis center. The facility staff failed to follow the facility policy, “Infection Control for Dialysis Facilities”. Cross Refer to Tag V 0111 B. 1. store vaccines in the refrigerator as recommended by the Centers for Disease Control (CDC). 2. ensure medications maintained in the facility are properly safeguarded and not accessible to unauthorized persons. Also, the facility staff failed to comply with the facility’s policy titled, “Medication Policy.” 3. ensure that medication vials are labeled when opened and initialed by the staff member. Cross Refer to Tag V 0117 C. monitor and provide a safe environment to store outside infectious waste. Cross Refer to Tag V 0121 D. ensure that dirty clamps were submerged in the bleach water. The bleach containers were used for cleaning and disinfecting non-disposable equipment. Also, the facility failed to follow its policy on “INFECTION CONTROL FOR DIALYSIS FACILITIES.” Cross Refer to Tag V 0122”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 29191 Based on observation, record review, and interview, the facility failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within the dialysis center. The facility staff failed to follow the facility policy, “Infection Control for Dialysis Facilities”. This deficient practice had the likelihood to cause harm to patients, staff members, and the public by increasing the risk of transmission of infectious agents within the facility. Findings Include: IN-CENTER TREATMENT AREA: * At the entrance to the treatment floor observed patients’ clean and sterile supplies stored in multiple plastic cabinets. Intravenous bags of solution, tourniquets, and “ExSept” (antimicrobial skin cleanser) were stored on the bottom shelf. The bottom shelf was directly on the floor. When the door of the cabinet opened the draft would pull dust and dirt particles onto the supplies. Observed dust and dirt particles on the bottom shelf with the clean and sterile supplies. * A cardboard box was observed stored directly on the floor in the storage room directly off the in-center treatment floor. The box was full of oxygen concentrator filters, computer parts, and cords. This box was mixed with the clean and sterile patient supplies. This room had been converted from an isolation room to a storage room. There were 3 wire racks with clean and sterile supplies stored on them. There was no barrier on the bottom shelf to prevent splash from sweeping and mopping by janitorial service. * A patient’s decorative personal pillow blue and white in color was stored on the open shelf on the in-center treatment floor. In the same cabinet area was a second shelf and observed a splatter of dried white substance. * Observed an orange colored dirty cloth that was on the shelf on the in-center treatment floor. The dirty cloth was stored on the shelf with a staff member’s stethoscope and box of gloves. * In the medication area which was designated as a clean sink observed a bio-hazard container. * The Hoyer lift located on the in-center treatment floor had an unclean appearance. Observed dust and dirt particles on the ledges of the lift. * The cart that held the disinfection bottles had an unclean appearance. The ridges in the cart had dirt, spillage, hair, and dark particles on the cart which was located on the in-center treatment floor. Next to the designated clean cart was a patient’s dirty wheelchair and a pair of dirty athletic shoes parked against the clean cart. * The dialysis chairs that were designated as “clean” and observed to have dirt and dust particles on the bottom of the chairs. The surveyor was able to manually remove dirt and dust particles with a wipe. LARGE SUPPLY ROOM * Observed a cart full of gallon bleach containers (20) that were being stored directly under the electric panel. WATER ROOM * A blue container labeled “caution corrosives” was sitting against the acid mixer that was leaking acid. * Observed a large amount of crystallized white substance under the acid mixer. Cardboard boxes harbor parasites, insects, and microorganisms. “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust.” (AAM1 ST46-Section 5.2 Receiving items). The CDC defines a “sanitary environment” as an environment that meets the “Standard Precautions” for an inpatient hospital setting plus the more stringent precautions which are recommended for hemodialysis units because of the increased potential for contamination with blood and pathogenic microorganisms. A review of facility policy, “Infection Control for Dialysis Facilities” dated, April 2023 revealed, “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. POLICY: The Centers for Disease Control (CDC) Recommendations for preventing the transmission of infections among chronic hemodialysis patients (Dialysis Precautions) will be followed when caring for all patients. Additional precautions recommended by the CDC are to be observed for patients with infectious hepatitis B ... DISINFECTION 12. 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) and prior to returning to clean/designated area or removal from treatment area. a. Prior to routine disinfection, remove all visible blood i. For visible blood or gross blood spills, a 1: 10 (one to ten) bleach solution must be utilized. ii. After all visible blood is cleaned with the 1: 10 (one to ten) bleach solution, teammates are to use a new disposable towel soaked with 1: 10 (one to ten) bleach solution and clean area a second time. iii. Cleaning of visible blood should be performed when first observed b. Use an appropriate disinfectant such as 1: 100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. i. Disinfection should be completed by using a wiping motion with friction. ii. Sufficient disinfectant should be applied so that surfaces are visibly wet. iii. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time iv. Items disinfected via submersion will be fully submerged 13. At the end of each treatment, the dialysis stations will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (i.e., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (i.e., control panel, top, front, and sides of a dialysis machine; touchscreens; countertops). i. The wall box, drain and water supply lines are considered part of the dialysis delivery system ... FACILITY HYGIENE 16. Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.” An interview with Staff # 1 on 12/13/2023 at 1:00 PM confirmed the facility had infection control issues and did not follow the facility’s infection control policy. Staff #1 acknowledged the treatment floor and storage room had some infection control issues.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 29191 Based on observation and staff interviews, the facility staff failed to A. store vaccines in the refrigerator as recommended by the Centers for Disease Control (CDC). These deficient practices had the likelihood to cause harm to all patients and staff receiving vaccines in the facility by not maintaining the medication at the correct temperature. B. ensure medications maintained in the facility are properly safeguarded and not accessible to unauthorized persons. Also, the facility staff failed to comply with the facility’s policy titled, “Medication Policy.” This deficient practice had the likelihood to cause harm by medication left unsecured and accessible to unauthorized staff. C. ensure that medication vials are labeled when opened and initialed by the staff member. This deficient practice had the likelihood to cause harm to patients by receiving expired medication. Findings include: A. On 12/13/2023 at 1:00 PM while on tour on the treatment floor observed vaccines were being stored against the wall of the refrigerator versus the center of the refrigerator as recommended by the Center for Disease Control (CDC). Review of CDC instruction for the storage of immunizations: https://www.cdc.gov/vaccines/hcp/admin/storage/index.html “Store between 35 and 46 degrees. Place the vaccine in bins with open airflow or leave the top off. Make sure the door is shut. Remove crisper bins and place water bottles labeled “Do Not Drink in the bottom. Leave 2-3 inches between all vaccine containers and refrigerator walls. Post do not unplug on the refrigerator. Don’t use the dormitory-style refrigerator. Don’t store vaccines on the top shelf Don’t put food and beverages in the refrigerator. Don’t put vaccines or diluents in the door or floor of the refrigerator. Don’t drink or remove water bottles.” An interview with Staff #21 on 12/13/2023 at 1:00 PM confirmed the vaccines were sitting against the wall of the refrigerator. B. During a tour of the treatment floor observed medications to be unsecured. Medication drawers at the nurse’s station #2 were unlocked, and the key was left unsecured in one of the drawers. The nursing staff were observed talking at another bay area which left no nurse where the medication was left unattended. Observed at nurse’s station #1 that medication bottles were being stored on the top of the medication counter unsecured. C. During a tour of the medication area at the nurse’s station #2 observed that a vial of Heparin 30,000 unit of medication was not labeled as to when the vial had been opened or by whom. At Nurse’s Station #1 found a vial of Epogen 20,000 units in the refrigerator, not labeled as to when opened or by whom. Epogen multidose vials must be discarded 21 days after opening or accessed. Medications containing a preservative must be discarded 28 days. A review of the facility’s policy titled, “ Medication Policy” with a revision date of October/2022 revealed the following: “PURPOSE: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. POLICY: 1. The Administrator/designee is responsible for supervising the handling, storing, disposing, administering, and controlling of medications and performs a monthly audit and inventory. 11. All refrigerated medications, for example, erythropoietin stimulating agents (ESA) and vaccines are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. 12. Controlled medications require completion of the medication formulary management process. If approved, daily accounting and disposition of these medications are documented in a log specifically for this purpose. Controlled medications, if administered in the facility, are stored in a safe, locked location that is not accessible to persons other than licensed nurse teammates and the Administrator/designee. 13. All open or unopened ampules and/or vials are stored according to the manufacturer’s directions. Do not use any ampule or vial that has been stored improperly or has expired. 15. When saline syringes must be prepared in an End Stage Kidney Disease (ESKD) facility for administration, the following safe injection practices must be followed: * Fill syringes with sterile saline for an individual patient in a dedicated clean area removed from the patient treatment area. Although not required, a clean room separate from the patient treatment area is the preferred location. * Prepare syringes for an individual patient as close as possible to the time of administration to prevent compromised sterility or stability. * Use aseptic technique for disinfection of saline vials prior to entry when preparing saline flushes including: * Medication containers labeled single-dose or single-use (e.g., saline bags, single-dose vials, ampules) may not be used to prepare flush syringes for more than one patient. Any unused saline in the opened single-dose or single-use container must be discarded and may not be stored for future use on the same patient. * If multi-dose vials are used to prepare saline flush syringes, they must be dated upon opening and discarded within 28 days unless the manufacturer specifies a different date for that vial. The beyond-use date should never exceed the manufacturer’s expiration date. 29. Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date or as directed by the manufacturer as in the case of vaccines or state-specific pharmacy regulations. Each vial is labeled with the initials of the person opening the vial and the expiration date. Medications are stored in the original vial and are not drawn up and stored overnight in a syringe or any other container. * Examples of manufacturer differing time lengths are, but are not limited to: Epogen multidose vials must be discarded 21 days after opening or accessed (e.g., needle punctured)” An interview with Staff #1 on 12/13/2023 at 1:00 PM confirmed the facility had not properly secured medications and/or the refrigerators that contained medication. Also, the staff had failed to label the vials of injectable medications that had been opened or accessed. Also, the vaccines were not stored according to the CDC guidelines.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 29191 Based on observation and interviews, the facility failed to monitor and provide a safe environment to store outside infectious waste. This deficient practice had the likelihood to cause harm by increasing the risk of infectious waste being made available to the public outside of the facility. The facility had two dumpsters on-site that were unsecured without a physical confinement surrounding it. The unsecured dumpsters allowed the public and rodents to pilfer through the trash. The wooden gates were off the hinges and lying against the wall which allowed the dumpsters to open to the public and the rodents. An interview with Staff #1 on 11/14/2023 at 2:00 PM confirmed the dumpsters were unsecured and were available to the public and allowed rodents to pilfer through the trash.”

“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: 29191 Based on observation and interview, the facility staff failed to ensure that dirty clamps were submerged in the bleach water. The bleach containers were used for cleaning and disinfecting non-disposable equipment. Also, the facility failed to follow its policy on “INFECTION CONTROL FOR DIALYSIS FACILITIES.” This deficient practice had the likelihood of causing harm to the patients by exposing patients to clamps that had not been disinfected. Findings include: During a tour of the in-center treatment floor observed two bleach containers that held white clamps. The white clamps were not completely submerged in the 1:100 bleach solution. There was no way to determine if the clamps were being disinfected per the policy procedure. A review of the policy titled, “ INFECTION CONTROL FOR DIALYSIS FACILITIES” dated April 2023 revealed the following: “14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station, and if contaminated between uses. If item cannot be cleaned and disinfected it will be dedicated for use on a single patient. a. Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution and if they are visibly contaminated with blood or body fluids should be disinfected with a 1:10 (one to ten) bleach solution. b. Hemostats (blood line clamps) should be in the open position and fully submerged in an appropriate disinfectant solution. For disinfection of vascular access clamps, please refer to policy: Utilizing Vascular Access Clamps c. Containers used to soak clamps, or other non-disposable equipment will be cleaned and disinfected at the conclusion of the day, or immediately after visible contamination.” An interview with Staff #1 on 12/13/2023 at 1:00 PM confirmed the white clamps were not submerged in the bleach solution to obtain disinfection.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed to ensure that the acid mixer and the transfer acid valve did not contain the contaminated acid solution from the acid build-up on the transfer valve outlets and acid mixer. This deficient practice had the likelihood to cause harm to all patients receiving in-center hemodialysis at the facility by receiving exposed contaminated acid. Findings include: On a tour of the water room on 12/13/2023, observed there was a white crystallized substance build-up around the transfer outlet valves and connectors. Also, a large amount of crystallized white substance build-up was underneath the acid mixer on the floor. An interview with Staff #2 on 12/13/2023 at 1:00 PM confirmed a large amount of acid (white crystallized substance) build-up underneath the acid mixer on the floor and acid build-up on the connectors of transfer outlet valves.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed: A. to ensure the R/O (reverse osmosis) solution was changed. R/O (reverse osmosis) solutions are only stable for 24 hours and should be dated with the current date. B. the facility’s direct care staff failed to know the process for obtaining the dialysate solution from the dialysis machine for conductivity and pH when the dialysis machine would not provide enough dialysate solution for the test. These findings had the likelihood to cause harm to all patients by using expired conductivity solutions to verify the conductivity of the dialysis machines. Findings include: A. The manufacturer’s instructions for the dialysis machines stated the conductivity should be checked with an independent device. The R/O (reverse osmosis) solutions are to be changed every 24 hours. During a tour of the treatment floor on December 13, 2023, observed on the treatment floor, two R/O bottles of the solution dated “12/12/2023”. Survey took place on 12/13/2023 A review of the guideline titled, “Checking Conductivity and pH of Final Dialysate with an independent method “ revealed the following: “Note: R/O water and 1% bleach solutions are replaced daily.” An interview with Staff #1 on 12/13/2023 at 1:00 PM confirmed the R/O bottles of the solutions were dated “12/13/2023”. B. During the observation of Staff #25 performing the conductivity before the patient was placed on the dialysis machine. The surveyor observed that Staff #25 was having difficulty getting dialysate solutions from the dialysis machine. Staff #25 stated, “I don’t know why I can’t get any dialysate solution.” Staff #25 asked another Staff member for assistance but no help. The Bio-medical technician was called to the floor, and he advised Staff #25 to speed up the flow on the dialysis machine and make sure that when getting dialysate solution from the Hanson connectors the lid to the Hansen connectors must be closed for the solution to be dispensed. A review of the facility policy titled, “OPERATION OF PORTABLE MYRON L CONDUCTIVITY METER (D-1)” with a revision date of April 2020 revealed, “NOTES: * Manual pH testing must be performed prior to each patient treatment. * Requirement for independent conductivity testing is determined by manufacturer’s guidelines. Refer to specific hemodialysis machine priming policies and procedures to determine the requirement of performing independent conductivity testing in the facility. * Fresh dialysis-quality water should be used for rinsing the D1 meter cell. Do not use pressurized or spray devices for cleaning the D1 meter. * If a separate container is used for dialysis quality water the container should be labeled with date and initials of teammate filling the container. * The exterior of D1 meter should be cleaned with 1:100 bleach solution after collecting a sample from another dialysis delivery system to prevention cross contamination. * Dialysis quality water should be used to rinse the plunger and cell cup of the D1 meter. The D-1 meter and calibration solutions should be located in a clean area. * The outside of the D-1 meter must be disinfected after use prior to returning the meter to the storage location. * The dipper end of the cell plunger will deliver the right amount of sample to be tested. * The plunger enclosed with the dialysate meter has been calibrated specifically for this instrument. If a different plunger is used, the dialysate meter must be recalibrated. Note: Verify that the container of fresh dialysis quality water used to rinse the D1 meter cell cup is labeled with today’s date and initials of the teammate if applicable.” Obtain proportioned dialysate sample per delivery system manufacturer’s recommendation utilizing the DI meter dipper side of the plunger or clean disposable collection cup. Fill meter cell cup with sample so upper electrode is immersed. Insert plunger. Agitate sample with plunger by moving up and down 3 or 4 times and then discard sample Repeat steps # 3 and # 4 - at least 3 times. Obtain another proportioned dialysate sample and fill the meter, drop plunger in the solution and press the black button. When the pointer stops, immediately read and release the button.” An interview with Staff # 2 and #25 confirmed Staff # 25 was not sure what the process was when obtaining the dialysate solution from the Hansen connectors when the dialysate solution would not dispense. Also, the facility failed to follow the policy on “OPERATION OF PORTABLE MYRON L CONDUCTIVITY METER (D-1)””

“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: 29191 Based on record review and interview, the facility staff failed to ensure direct care staff were reporting patient vital signs that fell outside of the facility’s set parameters to the CN (charge nurse) for further assessment and intervention on 1 (#1) of 1 patient chart reviewed. The facility staff failed to follow the facility policy “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment”. This deficient practice had the likelihood to cause harm to the patients at the facility by allowing the patients’ blood pressure to be hypertensive and causing a stroke. Findings include: Patient # 1 A review of the treatment sheet dated 07/31/2023 for Patient #1 revealed Staff #22 did not alert the charge nurse (CN) of abnormal vital signs during treatment. Staff #22 documented the following on 07/31/2023: “6:43 AM: BP (blood pressure): 229/125 (initial Blood Pressure) 8:32 AM: BP 234/132 8:05 AM: BP 202/104 patient discharged There was no documentation from Staff #22 to support the charge nurse being made aware of these abnormal vital signs during patient #1’s treatment on 07/31/2023. There was no documentation from a registered nurse addressing the high blood pressure. The physician was not notified of the high blood pressure. A review of the treatment sheet dated 08/02/2023 for Patient #1 revealed Staff #22 did not alert the charge nurse (CN) of abnormal vital signs during treatment. Staff #22 documented the following on 08/02/2023: “6:22 AM: BP (blood pressure): 247/131 (initial Blood Pressure) 07:05 AM: BP 243/130 10:20 AM: BP 232/127 13:21 AM: BP 218/102 08:30 AM: BP 241/123 10:20 AM: BP 231/106 09:30 AM: BP 240/130 09:54 AM: BP 209/98 patient discharged The times that were documented on the medical record were not consistent with the flow timing of the record. Registered Nurse #24 charted Clonidine 0.1 mg given at 13:21 (1:21 PM), but the treatment ended at 10:24 AM. There was no documentation of Clonidine being given on the treatment record under medication administered. The clonidine was only charted on the intradialytic vitals stat line. There was no documentation from Staff #22 to support the charge nurse being made aware of these abnormal vital signs during patient #1’s treatment on 08/02/2023. The registered nurse addressed the high blood pressure once during the treatment, but the blood pressure was out of range 8 times during the treatment. The physician was not notified of the high blood pressure. Staff #22 documented the following on 08/04/2023: “5:58 A BP (blood pressure): 240/117 (initial Blood Pressure) 6:32 AM: BP 243/127 07:02 AM: BP 234/106 07:14 AM: BP 217/101 07:32 AM: BP 205/93 08:02 AM: BP 212/105 08:32 AM: BP 211/104 09:02 AM: BP 243/119 09:35 AM: BP 204/94 patient discharged There was no documentation from Staff #22 to support the charge nurse being made aware of these abnormal vital signs during patient #1’s treatment on 08/04/2023. There was no documentation from a registered nurse addressing the high blood pressure. The physician was not notified of the high blood pressure. A review of the treatment sheet dated 08/09/2023 for Patient #1 revealed Staff #22 did not alert the charge nurse (CN) of abnormal vital signs during treatment. Staff #22 documented the following on 08/09/2023: “6:05 AM: BP (blood pressure): 266/148 (initial Blood Pressure) This blood pressure was documented by Registered Nurse #21 the physician was not notified. 06:30 AM: BP 252/133 07:00 AM: BP 252/133 08:02 AM: BP 242/141 08:32 AM: BP 230/117 09:02 AM: BP 213/127 09:32 AM: BP 225/120 10:02 AM: BP 227/124 10:15 AM: BP 211/101 patient discharged Registered Nurse #21 charted Clonidine 0.2 mg given at 6:14 AM and a second dose of Clonidine 0.1 mg given at 7:12 AM. There was no documentation that the physician was notified of the high blood pressure. There was no documentation from Staff #22 to support the charge nurse being made aware of these abnormal vital signs during patient #1’s treatment on 08/09/2023. The registered nurse addressed the high blood pressure twice during the treatment, but the blood pressure was out of range 9 times during the treatment. The physician was not notified of the high blood pressure. A review of the treatment sheet dated 08/12/2023 for Patient #1 revealed the following: Staff #16 documented the following on 08/12/2023: “6:02 AM: BP (blood pressure): 211/109 6:32 AM: BP 203/104 7:07 AM: BP 206/111 8:02 AM: BP 204/100 8:02 AM: BP 204/106 No documentation from Staff LVN #16 was reported to the registered nurse or the physician of the patient’s high blood pressure. A review of the treatment sheet dated 08/14/2023 for Patient #1 revealed the following: Staff RN #24 documented the following on 08/14/2023: “6:32 AM: BP (blood pressure): 230/120 07:02 AM: BP 220/131 07:17 AM: BP 229/135 07:32 AM: BP 236/127 08:02 AM: BP 214/121 08:06 AM: BP 208/114 08:32 AM: BP 221/112 09:02 AM: BP 230/113 09:32 AM: BP 228/116 10:02 AM: BP 229/115 10:10 AM: BP 205/113 No documentation from Staff RN #24 that the physician was notified of the high blood pressure. There was no Clonidine given for the high blood pressure. A review of the treatment sheet dated 08/16/2023 for Patient #1 revealed Staff #22 did not alert the charge nurse (CN) of abnormal vital signs during treatment. Staff #22 documented the following on 08/16/2023: “5:55 AM: BP (blood pressure): 205/115 (initial Blood Pressure) 06:32 AM: BP 205/120 07:16 AM: BP 207/110 08:02 AM: BP 242/141 The registered nurse addressed the high blood pressure once during the treatment, but the blood pressure was out of range 3 times during the treatment. The physician was not notified of the high blood pressure. A review of the treatment sheet dated 08/18/2023 for Patient #1 revealed the following: Staff RN #15 documented the following on 08/18/2023: “7:02 AM: BP (blood pressure): 248/131 07:32 AM: BP 243/138 08:02 AM: BP 212/112 08:32 AM: BP 229/124 09:02 AM: BP 221/115 09:09 AM: BP 230/126 09:32 AM: BP 218/111 10:02 AM: BP 224/128 10:24 AM: BP 209/103 No documentation from Staff RN #15 that the physician was notified of the high blood pressure. There was no Clonidine given for the high blood pressure. A review of the treatment sheet dated 08/23/2023 for Patient #1 revealed Staff #8 did not alert the charge nurse (CN) of abnormal vital signs during treatment. Staff #8 documented the following on 08/23/2023: “6:48 AM: BP (blood pressure): 242/133 (initial Blood Pressure) 07:04 AM: BP 260/164 07:34 AM: BP 268/150 08:02 AM: BP 253/136 08:32 AM: BP 245/132 09:03 AM: BP 245/127 09:32 AM: BP 215/137 10:04 AM: BP 262/129 10:16 AM: BP 256/119 patient discharged There was no documentation from Staff #8 to support the charge nurse being made aware of these abnormal vital signs during patient #1’s treatment on 08/23/2023. The nurse practitioner was on the treatment floor and the only orders were to have the patient take his blood pressure medications when patient #1 arrived at his home. Patient #1 passed away at home on 08/25/2023. A review of facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” with a revision date of October 2023 revealed the following: “PURPOSE: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment, and for reviewing the patient’s response to the treatment and status prior to discharge. POLICY: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. Data collection includes but is not necessarily limited to: *Measurement of patient temperature, measurement of blood pressure *Heart or pulse rate noting also if the beat is regular or irregular. *Patient weight *Patients report of well-being, level of pain or discomfort, complaints, hospitalization, and vascular access status. 2. The Nursing assessment will be performed and documented by a licensed nurse; specifically, a registered nurse (RN) ... a. The assessment includes the following components: i. Review of patient reports, data collection, complaints, and response to treatment. ii. Verification that machine safety checks have been completed and documented. iii. Verification of prescription including machine parameters. iv. Verification that the patient access is visible, and face is not covered ... 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment ... Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF profiling f. Blood Flow Rate g. Dialysate flow rate h. All access evaluated i. Correct dialysate composition (potassium, calcium, base sodium, and bicarb) and settings ... 4. Any abnormal findings pr findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse. If an abnormal findings is reported to the licensed nurse pre-treatment, the nurse will assess prior to the initiation of dialysis. 5. The assessment is nursing responsibility. The nurse will assess the patient pre-treatment as warranted by the patient’s condition. 6. The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if ay clinical interventions are necessary. The physician will be notified of any concerns that may preclude the initiation of dialysis ... 12. The licensed nurse notified the physician as needed of changes in patient status ... 17. Licensed nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician is necessary prior to discharge of the patient from the facility ...” A review of the facility document titled, “Pre-Treatment Reportable to the Charge Nurse (CN) revealed the following: “PCT reports to RN when: Blood Pressure: Systolic greater than 200 or less than 90 Diastolic greater than 100 or less than 50 Heart rate: greater than 110, less than 50 Report to CN for evaluation. CN to notify MD of pertinent.” An interview with Staff #1 on 12/13/2023 confirmed the facility staff were not reporting out-of-parameter vital signs to the Charge Nurse. Also, the facility staff failed to follow the facility’s policy.”