Renal Center of Nederland

“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: 29191 Based on observation and interview, the facility’s staff failed to ensure oxygen E-cylinders were secure in a holder This deficient practice had the likelihood to cause harm to a dialysis patient if the oxygen cylinder fell over and exploded in the facility. Findings include: During a tour of the facility on 04/15/2024 at 1:11 PM with Staff member #18 observed that four (4) oxygen E-cylinders were free-standing and not secured in a holder on the treatment floor. An interview with Staff #18 on 04/15/2024 at 1:11 PM confirmed the four oxygen E-cylinders were not secure in a holder on the in-center treatment floor.”

“INVENTORY CONTROL CFR(s): 494.50(b)(1) 9.2 Inventory control Reprocessing supplies should be used on a first-in, first-out basis, and outdated supplies should be identified and discarded. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff, the facility failed to ensure that outdated supplies were identified and discarded. Findings include: During observation of the lab area on 04/15/2024 at 1:00 PM, the following expired items were found: - Clear top blood tubes X 42 expired 05/2023 - Culture swabs X 5 expired 12/2023 In an interview with Staff #18 on 04/15/2024 at 1:00 PM acknowledged the clear top blood tubes and culture swabs had all expired in the year 2023.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility staff failed to: A. provide and monitor a sanitary environment to minimize the transmission of infectious agents in the Patient Lobby, Patient Supply Storage Room, and the In-Center Treatment Area. The facility staff failed to follow the “Infection Control for Dialysis Facilities” policy. (Cross Refer to Tag: V0111) B. ensure medications maintained in the facility were properly safeguarded and not accessible to unauthorized persons. The facility staff failed to follow the facility’s policy, “Medication Policy”. (Cross Refer to Tag: V177) C. follow the correct procedure for cleaning and disinfecting contaminated dialysis equipment and surfaces in the in-center treatment area. The facility staff failed to follow the “Infection Control for Dialysis Facilities” policy. (Cross Refer to Tag: V0122)”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed to: A. check and maintain the salt pellets above the water halfway mark in the brine tank. Cross refers to tag V190 B. ensure direct care staff had chlorine/chloramines test strips were within the date for monitoring the chlorine checks of the R/O (reverse osmosis) water system. Cross refers to tag V196 C. 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. Cross refers to tag V222 D. ensure the staff changed the filter on the acid mixer after the 6th batch of acid was mixed per the dry acid dissolution unit 132-gallon Technician’s manual. Cross refers to tag V226 E. to test the bicarbonate solution for conductivity or specific gravity prior to releasing the solution to the treatment floor as required. Cross refers to tag V229 F. ensure the bicarbonate mixing tank was labeled with the date, time, conductivity, and the staff that performed the bicarbonate mixing. Also, the facility staff failed to follow the facility’s policy on the bicarbonate mixing procedure. It was determined that the deficient practices at the following Conditions for Coverage for End-Stage Renal Disease facility posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death. Cross refers to tag V233 G. ensure direct care staff had implemented the facility’s policy and procedure when testing the dialysate solution with an independent meter for conductivity and pH before initiation of hemodialysis treatment on 2 (#6 and #7) of 2 patient observations. Also, the facility’s direct care staff failed to follow the facility’s policy on “MEASURING CONDUCTIVITY, TEMPERATURE AND/OR pH USING THE PHOENIX METER”. It was determined that the deficient practices at the following Conditions for Coverage for End-Stage Renal Disease facility posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death. Cross refers to tag V250”

“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: 48653 Based on observation, record review, and staff interview, the facility staff failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents in the Patient Lobby, Patient Supply Storage Room, and the In-Center Treatment Area. The facility staff failed to follow the “Infection Control for Dialysis Facilities” policy. 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. The CDC defines a “sanitary environment” as an environment that meets the “Standard Precautions” for an inpatient hospital setting plus the more stringent precautions that are recommended for hemodialysis units because of the increased potential for contamination with blood and pathogenic microorganisms. Findings include: During a tour of the facility on 03/11/2024 with Staff # 1 and Staff # 18 the following infection control issues were identified in the Patient Lobby, Patient Supply Storage Room, and In-Center Treatment Area. Patient Lobby During a tour of the patient lobby on 3/11/2024 at 12:30 PM the surveyor observed an expired hand sanitizer with an expiration date of “09/2023”. Also, there was a patient thermometer on the welcome counter that had dust on it. The thermometer had not been cleaned and disinfected. Patient Supply- Storage Room During a tour of the patient supply storage room on 3/11/2024 at 1:45 PM the surveyor observed clear, plastic bins with sterile patient supplies stored inside. The lids of the bins were left open, and dust and dirt particles were inside the bins. There were corrugated cardboard boxes stored above sterile patient supplies. The cardboard boxes and sterile patient supplies were stored together and not separated. 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). In-Center Treatment Area During a tour of the facility’s in-center treatment area on 3/11/2024 at 2:00 PM the surveyor observed the following: * Expired hand sanitizer at the patient scale with an expiration date of “09/2023” * Expired hand soap at the sink located near the patient scale with an expiration date of “03/2023” * Maroon-colored substance splashed on the inside of the sink located next to the patient scale. * Thick build-up of dust and dirt on the emergency code cart. * Dried blood spill located at Station # 4. The station had been designated as clean and ready for the next patient. * Blue clamps were not completely submerged in bleach water to ensure proper disinfection. The label on the bleach bucket container was illegible. It was unknown if the bleach water had been changed daily. * There were multiple blue clamps stored in a basket at the charge nurse’s desk. The basket had a build-up of dirt and dust in it as well as paper and binder clips. It was unknown if the clamps had been disinfected. * The cart used to store staff face shields was covered in a thick build-up of dust. The face shields were dirty and had a thick build-up of dirt and dust particles on them. The staff reported the face shields stored on the cart were considered clean. * The sink labeled “clean sink” had a thick build-up of a blue and brown substance inside it. The surveyor was able to remove the substance when it was wiped with a disinfectant solution. * Blood pressure cuffs had a build-up of unknown particles affixed to the Velcro portion of the cuffs. It was unknown if the cuffs had been disinfected due to the build-up of particles. * The chair at Station #16 had been designated as clean and ready to receive a patient. The chair had a build-up of dirt and dust on the footstool portion and in the crack between the seat and arm of the chair. * Expired hand sanitizer with an expiration date of “09/2023” was in use at the nurses’ station. * The tri-station had a thick build-up of dirt and dust inside of it. Also, there was hair, rusted screws, and other unknown particles located inside of it. * Oxygen tubing (nasal cannula) was found in a plastic Ziploc baggie at the nurses’ station. The baggie was not labeled, and it was unknown if the tubing had been used by a patient. Oxygen tubing is single patient use only. * Observed 4 of 4 supply carts located at the nurses’ stations were covered in a sticky tape residue. The tape residue had turned brown and could not be properly disinfected. * Observed 16 of 16 wall boxes had a build-up of a white substance inside. According to facility policy, wall boxes are to be cleaned at the end of each patient treatment. * There was a dried blood splatter on the floor and the dialysis machine’s tubing at Station # 7. Station # 7 was designated as clean and ready for the next patient. * The back of the dialysis machine at Station # 8 was dirty and had an orange and brown colored substance on it. Station # 8 was designated as clean and ready for the next patient. *The medication refrigerator had a build-up of black and brown substances on the bottom ledge of the refrigerator. The medication was stored directly above the substance. * There were 3 expired glucometer control solutions with expiration dates of 12/2023 and 6/2022 found at the nurses station. The expired supplies were available for staff use. * There were 2 box of expired glucometer test strips with an expiration date of 12/2023 found at the nurses station. The expired supplies were available for staff use. 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.” During an interview with Staff # 1, # 18, and # 20 on 03/11/2024 at 6:00 PM, the staff members acknowledged there were many infection control issues within the facility. All findings were observed by the staff members.”

“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: 48653 Based on observation, record review, and staff interview, the facility staff failed to ensure medications maintained in the facility were properly safeguarded and not accessible to unauthorized persons. Also, the facility staff failed to have a system for checking medication that had been combined together in a container with no expiration date. The facility staff failed to follow the facility’s policy, “Medication Policy”. During a tour of the facility’s in-center treatment area on 03/1/2024 at 2:30 PM, the surveyor observed 2 medication syringes labeled as “heparin” with Patient # 9’s identification affixed to them. The medication syringes were in an unlocked cabinet at the nurses’ station. The surveyor observed a cabinet at the nurses’ station labeled as a medication storage cabinet. The cabinet had a long, loose cable lock around the cabinet handles. The surveyor attempted to open the cabinet and was able to remove a box of heparin vials from the cabinet while the cable lock remained “locked” around the cabinet handles. The cabinet was not secure, and medications could be easily removed without unlocking the cable lock. The surveyor observed “Liquid Cel” packets (nutritional protein supplements) of several different flavors mixed in one container. The packets had no expiration dates, but when looking at the original box there were expiration dates on the box of each flavor. Each flavored box had a different expiration date. There was no way for the facility staff to know when the packets would expire. The “Liquid Cel” packets were available for staff use and patient consumption. A review of the facility policy, “Medication Policy” with a revision date of October 2023 revealed, “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 Facility 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. 23. Medications and needle/syringe storage are done in accordance with state regulations.” During an interview with Staff #18 on 03/11/2024 at 3:00 PM, Staff #18 acknowledged the medications were unsecured and the facility staff were not following the medication policy. Also, Staff #18 acknowledged that the expiration dates on the nutritional packets were different and by the staff mixing the packets in the same container there was no way to know the expiration date of the packets.”

“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: 48653 Based on observation and interview, the facility staff failed to follow the correct procedure for cleaning and disinfecting contaminated dialysis equipment and surfaces in the in-center treatment area. The facility staff failed to follow the “Infection Control for Dialysis Facilities” policy. These findings had the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by allowing supplies and equipment to be used that had been exposed to microbial contamination and unclean surfaces. During a tour of the facility’s in-center treatment area on 03/11/2024 at 2:30 PM the following was observed: Staff # 15 was observed cleaning dialysis Stations # 7 and # 8 after the completion of patient treatments. Staff # 15 did not thoroughly clean the dialysis stations. The surveyor observed a dried blood spill and an orange and brown substance on the back of the dialysis machines after Staff # 15 had completed the cleaning. Observed Staff #15 cleaning the chair side, but the wall box was not cleaned The boxes were noted to have crusted white sediment that was leaking down the wall box. The wall box, drain and water supply lines are considered part of the dialysis delivery system. Staff # 15 was observed transferring Patient # 4 to a wheelchair using the Hoyer lift. Staff # 15 did not disinfect the Hoyer lift after the transfer of Patient # 4. A review of the facility’s 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 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 03/11/2024 at 3:00 PM confirmed the facility staff were not consistently disinfecting surfaces within the in-center treatment area according to facility policy and manufacturer guidelines.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed to check and maintain the salt pellets no lower than the water halfway mark in the brine tank. This deficient practice had the likelihood to cause the water to become hard, failure to ensure adequate salt levels in the brine tank can lead to water hardness in the system at levels unacceptable for dialysis being performed on patients. Findings include: During a tour of the facility’s water room on 03/11/2024 at 1:15 PM observed the salt pellets were below the water level in the brine tank. An interview with Staff #18 on 03/11/2024 at 1:15 PM confirmed Staff #18 visualized the salt pellets in the brine tank below the water line.”

“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 03/11/2024 at 1:13 PM, observed there was a white crystallized substance build-up around the transfer outlet valves and connectors. An interview with Staff #18 on 03/11/2024 at 1:13 PM confirmed a large amount of acid (white crystallized substance) acid build-up on the connectors of transfer outlet valves.”

“MIX SYS-DFU/MONITOR/PM/LOG/SANITIZE CFR(s): 494.40(a) 5.4.4.1 Mixing systems: follow DFU/monitor/PM/log/sanitization If a concentrate mixing system is used, the preparer should follow the manufacturer’s instructions for mixing the powder with the correct amount of water. If a concentrate mixing system is used, the number of bags or the weight of powder added should be determined and recorded. Manufacturer’s recommendations should be followed regarding any preventive maintenance and sanitization procedures. Records should be maintained indicating the date, time, person performing the procedure, and results (if applicable). 6.4.1 Mixing systems: Systems for preparing either bicarbonate or acid concentrate from powder should be monitored according to the manufacturer’s instructions. This Standard is not met as evidenced by: 29191 Based on record review and interview, the facility failed to ensure the staff changed the filter on the acid mixer after the 6th batch of acid was mixed per the dry acid dissolution unit 132-gallon Technician’s manual. This deficient practice had the likelihood of causing harm by mixing the wrong mixture of acid for the dialysis patient due to a dirty acid filter. Findings include: During a tour of the water room on 03/11/2024 at 11:00 AM observed the acid filter on the acid mixer was dark brown. A review of the Granuflo Mixing log for March 2024 revealed that the acid filter was documented as changed on 02/30/2024. There was no such date. The filter was dark brown. The filter housing holding the filter was rusted with white splatter and dirty in appearance. An interview with Staff #17 on 3/11/2024 at 3:00 PM stated, “I changed the filter I just wrote it wrong.” Staff #17 did say what date the filter was changed. Staff #17 attempted to change the filter but was unable to get the housing off. A review of the dry acid dissolution unit 132-gallon Technician’s manual revealed the following procedure for changing the acid filter. “4.4 Filter maintenance The I-micron filter should be changed under the following conditions: 1. After mixing 6 batches of Dry Acid concentrate. 2. When the Dry Acid Dissolution Unit (DADU) requires disinfection. NOTE: IT IS RECOMMENDED TO REPLACE THE FILTER AFTER MIXING 6 BATCHES OR IF THE TANK REQUIRES DISINFECTION.” An interview with the Bio-Medical Director (ATOM) #19 on 03/11/2024 at 5:00 PM confirmed the acid filter had not been changed after the 6th batch of acid was mixed and that a new housing for the filter will have to be ordered.”

“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: 29191 Based on record review and interview, the facility staff failed to test the bicarbonate solution for conductivity or specific gravity prior to releasing the solution to the treatment floor as required. This deficient practice had the likelihood to affect all 78 in-center hemodialysis patients receiving care at the facility. Findings include: During a tour of the water room on 03/11/2024 at 1:21 PM, the surveyor observed the bicarbonate tank sign contained a date of 03/08/2024, and time of mixing, and the initial of the staff member mixing the bicarbonate. A review of the bicarbonate mixing log from 02/01/2024 through 02/29/2024 revealed there was 18 days that there was no documentation of conductivity or specific gravity checks completed. An interview with the Bio-medical technician (Staff # 11) on 03/11/2024 at 3:00 PM confirmed staff do not record the testing of the bicarbonate solution consistently. Staff #11 stated, “The staff have been in-serviced on documenting the conductivity but continue to miss logging the conductivity results on the log.” Staff #11 confirmed they did not check conductivity or a specific gravity before transferring the bicarb solutions to the treatment floor. Staff #11 confirmed this was not best practice and confirmed the Association for the Advancement of Medical Instrumentation (AAMI) standards state the facility must set a range before transfer if the bicarbonate manufacturer had not specified a range. A review of the facility policy titled, “Better Water-Central Bicarb Mixing and Delivery” dated October 2023, revealed the following: “16. Document date, time, expiration date on bicarb bags if applicable, lot number, manufacturer, # bags added, test results and signature of teammate preparing and testing solution and verifier signature on the appropriate Bicarb Mixing Log. “ Rationale: Conductivity and /or Specific gravity may be used to check proper concentration. Consult facility protocol. If solution is outside the range, do not use, contact Biomed department for assistance.” The federal regulations adopted the ANSI/AAMIRD52:2004 which gives guidance on the mixing of Bicarbonate and revealed the following: “The mixing logs must demonstrate complete documentation of this required information. Test results may include conductivity or specific gravity. Facility policy must stipulate the expected ranges for the test(s) used to verify correct mixing. Standards used to calibrate the instrument used to measure conductivity should encompass the expected results; for example, it would be unacceptable to use a “14” standard for an expected result of “70.” “Verifying mixing and test results” means the staff member performing this task checks the results against the expected ranges for the test and does not release mixtures for use that test outside those ranges.” An interview with staff #11 on 03/11/2024 at 3:30 PM acknowledged that facility staff failed to document the bicarbonate solution on the “Bicarb mix log-Conductivity with Myron L4P or 6P””

“BICARB MIX SYS-STOR/USE TIME/MIN COMBINE CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: storage/use time limits/min combine Once mixed, bicarbonate concentrate should be used within the time specified by the manufacturer of the concentrate. 7 Strategies for bacterial control 7.1 General Storage times for bicarbonate concentrate should be minimized, as well as the mixing of fresh bicarbonate concentrate with unused portions of concentrate from a previous batch. The manufacturer’s instructions should be followed if they are available. This Standard is not met as evidenced by: 29191 Based on observation, and interview, the facility staff failed to ensure the bicarbonate mixing tank was labeled with the date, time, conductivity, and the staff that performed the bicarbonate mixing. Also, the facility staff failed to follow the facility’s policy on the bicarbonate mixing procedure. It was determined that the deficient practices at the following Conditions for Coverage for End-Stage Renal Disease facility posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death. This deficient practice had the likelihood of causing Metabolic Alkalosis to patients receiving bicarbonate solutions that had been mixed for more than 24 hour. Findings included: During a tour of the water room on 03/11/2024 at 12:30 PM observed the following issue: The bicarbonate mixing tank in the water room had a date of 3/8/24 and a time of 4:00 AM. The survey date was 03/11/2024. There were 16 patients receiving dialysis. The bicarbonate tank had a flip chart that read disinfectant and rinse indicating that there was bleach in the bicarbonate tank. The manufacturer guideline recommends no longer than 24 hours for the bicarbonate to be mixed due to bacteria growth. A review of the policy titled, “BICARB MIXING AND DELIVERY” dated October 2023 revealed the following: “NOTES: Mixed Bicarbonate solution is discarded at the end of the treatment day. Document the date, time, and expiration date on bicarb bags if applicable, lot number, manufacturer, # bags added, test results, and signature of the teammate preparing and testing solution and verifier signature on the bicarbonate mixing log. Verify that the tanks are labeled with contents in tank, date, time, and initials.” An interview with Staff #18 on 03/11/20242 at 12:30 PM confirmed the bicarbonate mixing tank had a date of 03/08/24 and that it was labeled disinfectant and rinse.”

“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. the facility’s direct care staff failed to implement the facility’s policy and procedure when testing the dialysate solution with an independent meter for conductivity and pH before initiation of hemodialysis treatment on 2 (#6 and #7) of 2 patient observations. Also, the facility’s direct care staff failed to follow the facility’s policy on “MEASURING CONDUCTIVITY, TEMPERATURE AND/OR pH USING THE PHOENIX METER”. It was determined that the deficient practices at the following Conditions for Coverage for End-Stage Renal Disease facility posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death. B. 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. This deficient practice had the likelihood to cause harm to the patients being dialyzed in the facility by not checking the conductivity and pH before the initiation of dialysate. Also, the staff not using a stable R/O solution that was stable could change the conductivity and pH of the dialysate. Findings include: A. Observed Staff #15 on 3/11/2024 at 2:00 PM not performing the conductivity before the patient was placed on the dialysis machine. The surveyor observed that Staff #15 initiated the dialysis treatment without performing the conductivity with an independent device (PHOENIX meter). Observed Staff #23 not performing the conductivity before the patient was placed on the dialysis machine. The surveyor observed that Staff #23 set- up the dialysis machine with the dialysis tubing. Patient #7 registered nurse initiated the dialysis treatment without performing the conductivity with an independent device (PHOENIX meter). This patient had a central venous catheter (CVC) so only a licensed nurse can initiate treatment. A review of the documentation of the conductivity on the computer showed a manual conductivity of 13.6 and a machine of 13.6. In an interview with staff #7 on 3/11/2024 at 2:30 PM was asked about performing conductivity before initiating treatment. Staff #7 stated, “No, but I can see it is documented under my name because I made the last entry. The surveyors watched the 3 Phoenix meters’ positions while observing the direct care staff, and the meters never left their positions. Sixteen patients were running on dialysis machines on the day of the survey. A review of the facility policy titled, “ MEASURING CONDUCTIVITY, TEMPERATURE AND/OR pH USING THE PHOENIX METER) with a revision date of April 2022 revealed, “NOTES: * Dialysis-quality water should be obtained fresh same day of use prior to use with this procedure. * The exterior of Phoenix meter should be cleaned with 1:100 bleach solution prior to collecting a sample from another dialysis delivery system to prevent cross-contamination. * The Tri-Station along with drain line is a clean station and should be located in a clean area. *Dialysate and the fluids used to disinfect, calibrate, and store Phoenix meters are also considered clean. * Manufacturer’s drain line is limited to 5 feet and should be replaced by Biomed at least annually or sooner if drain line is discolored or contains evidence of buildup. * The outside of Phoenix meter must be disinfected after use prior to returning the meter to the storage location.” B. 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 3/11/2024, observed a bottle R/O solution not dated. 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 #18 on 3/11/2024 at 2:30 PM confirmed the R/O bottle of the solution was not dated. Also, Staff #18 acknowledged that the direct care staff were not performing conductivity on the machines before initiating treatment.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 48653 Based on observation and staff interviews, the facility staff failed to ensure the emergency pull cord (a call light strategically placed throughout the facility to provide a user with a convenient means of summoning help in an emergency) was accessible for a patient in the event of an emergency. The emergency pull cord should be within 6 inches of the floor, hanging freely, and accessible to patients. Upon entering the facility’s lobby on 03/11/2024 at 12:30 PM, the surveyor observed the emergency pull cord inaccessible and blocked by multiple patient wheelchairs. In an interview with Staff #1 on 03/11/2024 at 5:00 PM Staff # 1 acknowledged the pull cord was blocked and inaccessible to patients in the event of an emergency.”

“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: 48653 Based on record review and staff 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 4 (# 1 # 2 # 6 # 8) of 4 patient charts reviewed. The facility staff failed to follow the facility policy “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment”. Findings include: Patient # 1 A review of the treatment sheet dated 01/02/2024 for Patient # 1 revealed Staff # 3 (Charge Nurse) initiated treatment and documented the following vital signs: “11:17 AM: BP (blood pressure): 170/107; HR (heart rate): 147” The patient continued to have out-of-parameter vital signs throughout treatment without notification to the MD. The following vital signs were documented: “11:32 AM: BP:173/118; HR: 161 11:51 AM: 171/114; HR: 164” There is no documentation from Staff # 3 to support the MD being made aware of Patient # 1’s condition throughout treatment. Staff # 1 did not notify the MD of the patient’s vital signs or condition before initiating treatment. Patient # 2 A review of the treatment sheet dated 11/01/2023 for Patient # 2 revealed Staff # 16 did not notify the charge nurse of out-of-parameter vital signs that occurred throughout treatment. Staff # 16 documented the following vital signs: “1:01 PM: BP: 87/40 1:13 PM: BP: 72/53” There is no documentation from Staff # 16 to support the Charge Nurse being made aware of the out-of-parameter vital signs. Staff # 3 (Charge Nurse) documented the following vital signs on 11/01/2023: “1:14 PM: BP: 88/59” 1:27 PM: BP: 66/47” There is no documentation from Staff # 3 (Charge Nurse) to support the MD being made aware of the out-of-parameter vital signs. The patient was coded during treatment and was transferred to the hospital. The patient was announced deceased on 11/01/2023. Patient # 6 A review of the treatment sheet dated 03/06/2024 for Patient # 6 revealed the facility staff did not report out-of-parameter vital signs to the CN and MD. Staff # 21 documented the following vital signs: “3:46 PM: HR: 32 4:06 PM: BP: 77/49” There was no documentation from Staff # 21 to support the CN and MD being made aware of the out-of-parameter vital signs. Staff # 22 (RN) documented the following vital signs: “5:34 PM: BP: 57/45; HR 111” There is no documentation from Staff # 22 to support the MD being made aware. Staff # 22 terminated treatment and the patient was discharged. Patient # 8 A review of the treatment sheet dated 11/27/2023 for Patient # 8 revealed the facility staff did not report out-of-parameter vital signs to the CN and MD. Staff # 15 documented the following vital signs: “12:45 PM: BP: 83/39” There was no documentation from Staff # 15 to support the CN being made aware of the out-of-parameter vital signs. Staff # 3 documented the following vital signs: “2:01 PM: BP: 50/25; HR 46” Staff # 3 documented the patient was unresponsive and treatment was terminated. The patient was sent to the emergency room for further evaluation and treatment. There is no documentation to support the MD being made aware of the patient’s vital signs throughout treatment. A review of facility policy, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” dated April 2021 revealed, “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. PRE-TREATMENT DATA COLLECTION/ASSESSMENT 4. Any abnormal findings or findings outside of any patient-specific physician-ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to ‘abnormal findings’ section of this policy). If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 6. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner) will be notified of any concerns that may preclude the initiation of dialysis. 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 the ‘abnormal findings’ section of 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 responses will be documented in the patient’s medical record. ABNORMAL FINDINGS Blood pressure: Pre-dialysis: * Systolic greater than 180 mm/Hg or less than 90 mm/Hg * Diastolic greater than or equal to 100 mm/Hg Blood Pressure-Intradialytic: * Difference of 20 mm/Hg increase or decrease from the patient’s last intradialytic treatment BP reading * Signs/symptoms of hypotension may include: * Nausea and vomiting * Cold and clammy skin * Restlessness * Rapid, shallow respirations * Excessive yawning * Diaphoretic Blood Pressure Post Treatment: * Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg * Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg Heart or Pulse Rate Pre/Intra/Post: * Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heartbeat” During an interview with Staff # 1 on 03/11/2024, Staff # 1 reported the facility staff were not compliant with treatment sheet documentation. Staff # 1 stated, “The team has received in-services regarding recent treatment sheet audits.””