Davita Seaway Dialysis

“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: 34528 Based on policy review, observation, and interview, nursing staff did not ensure that patients holding their cannulation/needle access sites perform hand hygiene after treatment. Findings include: Review of the policy “Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles,” last revised 04/2023 indicated the patient will be encouraged to hold their own sites if their condition permits. When holding their cannulation sites, the patient will be offered gloves and will perform hand hygiene when completed. Observation on 11/20/24 at 10:15 AM at Station #4 revealed Patient # 23 held their needle insertion sites after the removal of both needles to stop the bleeding without wearing gloves and did not perform hand hygiene before leaving the unit. Observation on 11/20/24 at 10:30 AM at Station #9 revealed Patient # 19 held their needle insertion sites after the removal of both needles to stop the bleeding with a gloved hand and did not perform hand hygiene before leaving the unit. Interview on 11/20/24 at 10:00 AM with Staff (F), Facility Administrator, verified these findings.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 34528 Based on policy review, observation, and interview, nursing staff do not wear personal protective equipment (PPE) appropriately while performing procedures during which the spurting or spattering of blood might occur. Findings include: Review of the policy “Infection Control For Dialysis Facilities,” revised 04/2023 revealed appropriate personal protective equipment (gowns, gloves, eye protection, face shield) will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment, and environmental surfaces, for example patient care areas. Observation on 11/18/24 at 02:00 PM in the isolation room revealed Staff (I), Patient Care Technician, wore their mask under their nose while removing needles from Patient #12 fistula (hemodialysis access). Observation on 11/18/24 at 02:45 PM at Station #17 revealed Staff (I), Patient Care Technician, wore their mask under their nose while removing the needles from Patient #13’s fistula. Interview on 11/20/24 at 02:00 PM with Staff (F), Facility Administrator, verified these findings.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 34528 Based on policy review, observation, and interview, nursing staff do not ensure items taken into the hemodialysis station are cleaned and disinfected before being taken back to a common, clean area to be used on another patient. Findings include: Review of the policy “Infection Control for Dialysis Facilities,” revised 04/2023 indicated unused supplies (syringes, alcohol swabs, tape, etc.) or medications taken into the station should be used only for that patient and should not be returned to a common clean area. The chairside cart, terminals mounted on the counter, monitor, and keyboard are considered clean areas. Observation on 11/20/24 at 02:50 PM at Station #2 revealed Staff (H), Patient Care Technician entered the station with anesthetic spray (numbing solution) bottle and placed it on the tray table connected to the dialysis chair while cannulating (insert needles) Patient #14. Staff (H) exited the station after initiating treatment and returned the anesthetic spray to the computer cart (holds the computer monitor and keyboard) located next to the station, without disinfecting the spray bottle. Interview on 11/20/24 at 02:30 PM with Staff (F), Facility Administrator, verified these findings.”

“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: 34528 Based on policy review, observation, and interview, nursing staff do not properly handle and/or dispose of potentially infectious waste. Findings include: Review of the policy “Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles,” last revised April 2023 indicated to remove needle (s) and dispose in the sharps container (used to contain needles or other sharp objects). Observation on 11/20/24 at 10:15 AM at Station #4 revealed Staff (H), Patient Care Technician, removed both the venous and arterial needles from Patient #23’s fistula, and placed the needles on the chairside table while they continued with post treatment access care. Staff (H) did not immediately dispose the needles into the sharp’s container. Observation on 11/20/24 at 10:35 AM at Station #20 revealed Staff (M), Registered Nurse, removed both the venous and arterial needles from Patient #18’s fistula, and placed the needles on the chairside table while they continued with post treatment access care. Staff (M) did not immediately dispose the needles into the sharp’s container. Interview on 11/20/24 at 10:00 AM with Staff (F) Facility Administrator, verified these findings.”

“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: 16136 Based on document review, observation, and interview, the facility does not ensure that the salt level in the brine tank is above the water level. Findings include: Review of the “Mar Cor Purification Hemodialysis Water Treatment System Operation and Maintenance Manual,” indicated the salt level in the brine tank must be above the water level to ensure a saturated sodium chloride (salt) solution is drawn during regeneration of the softener tank. Observation on 11/20/24 at 09:40 AM in the water room revealed that the salt level in the brine tank was approximately six to eight inches below the water level. Interview on 11/20/24 at 09:45 AM with Staff (K), Patient Care Technician, verified these findings.”

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that the water hardness obtained at the end of the treatment day is within facility established parameters. Findings include: Review of the policy “Hardness Test using RPC (brand name) Water Hardness Test Strips,” reviewed 09/2015 indicated staff are to notify biomed teammate and facility administrator/designee if end of day hardness test result are greater than one grain/gallon. Review of the “CWP (Cold Water Plant) Water Log,” from 05/2024 thru 10/2024 revealed that the end of day hardness test level was three grains/gallon for 11 of 14 days in 05/2024, 10 of 12 days in 06/2024, 8 of 14 days in 07/2024, 3 of 11 days in 08/2024, 1 of 11 days in 09/2024, and 3 of 14 days in 10/2024. There was no evidence that staff notified the biomed teammate, or the facility administrator/designee of the out-of-range water hardness results greater than one grain/gallon. Interview on 11/19/24 at 01:40 PM with Staff (E), Biomed Technician, verified this finding.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that daily water readings are obtained, and the readings are within facility established parameters. Findings include: Review of the policy “Daily Water Treatment System Monitoring,” reviewed 04/2023 indicated all observations and test results must be recorded on the “Daily Water Treatment Log.” The teammate completing the log will notify the facility administrator/designee and biomed teammate of any observation or test result found outside the limit specified on the log. A licensed nurse will review the log for completeness and verify all parameters are within specified limits. The licensed nurse will initial and sign the log. Review of the “Daily Water Treatment Log,” from 05/2024 thru 10/2024 revealed water readings were not obtained daily on 05/06/24, 08/05/24, 08/07/24, 08/09/24, 09/02/24, 09/04/24, 09/06/24, 10/11/24, and 10/25/24. Review of the “Daily Water Treatment Log,” from 05/2024 thru 10/2024 revealed the following: The feed water temperature parameters are (greater than 60 degrees - less than 85 degrees Fahrenheit). Test results exceeded these parameters in the following months: -In May on 05/29/24 and 05/31/24. No test results were provided for 05/06/24. -In June on 06/03/24, 06/05/24, 06/07/24, 06/12/24, 06/17/24, and 06/28/24. -In July on 07/01/24, 07/03/24, and 07/05/24. Pure water flow rate parameters are greater than or equal to 15 liters per minute. Test results exceeded these parameters in the following months: -In May on 05/03/24, 05/13/24, and 05/22/24. -In June on 06/03/24, and 06/17/24. -In July on 07/29/24, and 07/31/24. -In August on 08/03/24, 08/16/24, 08/19/24, 08/21/24, 08/23/24, 08/26/24, 08/28/24, and 08/30/24. -In September on 09/09/24, 09/11/24, 09/13/24, 09/16/24, 09/18/24, 09/20/24, 09/23/24, 09/25/24, 09/27/24, and 09/30/24. -In October on 10/02/24, 10/04/24, 10/07/24, 10/09/24, 10/11/24, 10/14/24, 10/16/24, 10/18/24, 10/21/24, 10/23/24, 10/25/24, and 10/28/24. Loop return flow rate parameters are greater than or equal to one liter/minute. Test results exceeded these parameters in the following months: -In May on 05/03/24, 05/10/24, 05/13/24, 05/15/24, 05/20/24, 05/22/24, 05/24/24, and 05/29/24. -In June on 06/03/24. -In July on 07/29/24, and 07/31/24. -In August on 08/02/24, 08/03/24, 08/12/24, 08/14/24, 08/16/24, 08/19/24, 08/21/24, 08/23/24, 08/26/24, and 08/30/24. -In September on 09/09/24, 09/11/24, 09/13/24, 09/16/24, 09/18/24, 09/20/24, 09/23/24, 09/25/24, 09/27/24, and 09/30/24. -In October on 10/02/24, 10/04/24, 10/07/24, 10/09/24, 10/11/24, 10/14/24, 10/16/24, 10/18/24, 10/21/24, 10/23/24, 10/25/24, and 10/28/24. Pure Water Conductivity parameters are less than 15 micro siemens. Test results exceeded these parameters in the following months: -In July on 07/17/24, 07/19/24, 07/22/24, 07/24/24, 07/26/24, 07/29/24, and 07/31/24. -In August on 08/02/24, 08/03/24, 08/12/24, 08/14/24, 08/16/24, 08/19/24, 08/21/24, 08/23/24, 08/26/24, 08/28/24, and 08/30/24. -In September on 09/09/24, 09/11/24, 09/13/24, 09/16/24, 09/18/24, 09/20/24, 09/23/24, 09/25/24, 09/27/24, and 09/30/24. -In October on 10/02/24, 10/04/24, 10/07/24, 10/09/24, 10/11/24, 10/14/24, 10/16/24, 10/18/24, 10/21/24, 10/25/24, 10/28/24, and 10/31/24. A licensed nurse reviewed and signed off on the logs. There is no evidence to indicate the facility administrator and/or the biomed teammate were notified of the readings not within facility established parameters and/or if any corrective actions were taken. Interview on 11/19/24 at 02:15 PM with Staff (E), Biomed Technician, verified these findings.”

“DI-CONTIN MONITOR/LOGGED 2X/DAY CFR(s): 494.40(a) 5.2.8 Deionization: continuous monitor resistivity/logged 2 X day Refer to RD62:2001, 4.3.6 Deionization: Deionization systems, when used to prepare water for hemodialysis applications, shall be monitored continuously to produce water of one megohm/cm or greater specific resistivity (or conductivity of one microsiemen/cm or less) at 25°C. 6.2.8 Deionization Deionizers shall be monitored continuously using resistivity monitors that compensate for temperature and are equipped with audible and visual alarms. Resistivity monitors shall have a minimum sensitivity of 1.0 megohm-cm. Patients shall not be dialyzed on deionized water with resistivity less than 1.0 megohm-cm measured at the output of the deionizer Resistivity monitor readings should be recorded on a log sheet twice each treatment day. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that documentation is maintained when the facility utilizes DI (deionization-removes positive and negatively charge ions from the water) tanks. Findings include: Review of the policy “Daily Water Treatment System Monitoring,” reviewed 04/2023 indicated when DI is used in a facility, in the event the RO (reverse osmosis-purifying water for dialysis treatments) is inoperable or as a polish (removes positive and negatively charge ions from the water), the “DI Monitoring Log” will be implemented. The resistivity (the ability of water to resist electrical currents determined by the salts in the water) monitor readings will be recorded on the log every four hours of each treatment day. This should be in occur parrell when performing and documenting chlorine checks. Review of the document “Biomed Report” dated 07/2024 indicated the facility used DI tanks to polish the treated water utilized for dialysis treatments. The RO membranes were not able to produce dialysis water due to the “membranes being exposed to extremely hard water for long periods of time,” resulting in high conductivity ( a parameter for measuring the total concentration of salt) readings from the RO unit. Review of the “CWP Daily Water Log,” for July 2024 did not document DI tanks were being utilized. No documentation was found to indicate staff implemented the DI Monitoring Log. No documentation of the monitoring of the resistivity for the DI tanks every four hours when the DI tanks were being used was found. Interview on 11/20/24 at 11:15 AM with Staff (E), Biomed Technician, and at 11:30 AM via telephone with Staff (P), Biomedical Operations Manager, verified this finding.”

“HOT H20 DISINF SYS-MONITORING CFR(s): 494.40(a) 6.3.4 Bacterial control devices 6.3.4.3 Hot water disinfection systems: monitoring Hot water disinfection systems should be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Also, hot water disinfection should be performed at least as often as recommended by the manufacturer. The temperature of the water should be recorded at a point farthest from the water heater-that is, where the lowest water temperature is likely to occur ...and measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection should be maintained. Successful completion is defined as meeting temperature and time requirements specified by the equipment manufacturer. This Standard is not met as evidenced by: 16136 Based on document review and interview, the facility does not ensure that an acceptable hot water return temperature on the Central Water Plant (CWP) has been obtained from the farthest point on the distribution loop (loop that provides treated water to each dialysis station) when hot water is utilized to disinfect the water system. Findings include: Review of the manufacturer recommendations “Mar Cor Purification, CWP 100, Model H/S, Revision B,” 2012 indicated the return hot water from the distribution loop from the farthest point should be 85 degrees Celsius. Review of the “CWP Daily Water Log,” dated 05/2024 through 11/2024 did not documented when hot water was utilized to disinfect the water system daily or monthly and did not include temperatures to ensure the heat disinfection cycle was completed successfully. Interview on 11/20/24 at 11:15 AM with Staff (E), Biomed Technician, and at 11:30 AM via telephone with Staff (P), Biomedical Operations Manager, verified this finding.”

“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: 16136 Based on document review, observation, policy review, and interview, the facility does not ensure the bicarbonate solution (kidney failure causes the body to become acidic, this solution helps to maintain balance) is mixed per manufacturer recommendations. Findings include: Review of the manufacturer recommendations “NaturaLyte Dry Bicarbonate,” indicated staff are to add the dry bicarbonate powder into 180 liters of dialysis water gradually while gently mixing the solution and mix for one minute. Staff are to add additional dialysis water to equal a total volume of 192 liters and mix again until powder is completely dissolved in solution for approximately 10 minutes. Observation on 11/20/24 at 01:10 PM in the water room revealed Staff (K), Patient Care Technician added 50 gallons (190 liters) of dialysis water into Bicarbonate Tank #1, added two bags of dry bicarbonate powder to the tank, and mixed the solution for 10 minutes. Interview on 11/20/24 at 03:00 PM with Staff (F), Facility Administrator, and Staff (E), Biomed Technician, verified this finding.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 16136 Based on observation and interview, the facility does not ensure that the acid jugs are properly labeled. Findings include: Observation on 11/18/24 at 10:30 AM, on a black cart behind the nurse’s station revealed four 2.6 gallon concentrate jugs labeled on top as “2.0 K 2.5 CA acid concentrate.” On the side of the concentrate jugs, the labeling indicated the jugs were “acetic acid.” Interview on 11/18/24 at 10:45 AM with Staff (B), Nurse Manager, and on 11/20/24 at 03:00 PM with Staff (E), Biomed Technician, verified this finding.”

“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: 16136 Based on policy review, document review, and interview, the facility does not ensure that the documentation for the bicarbonate mixing log is complete. Findings include: Review of the policy “Facility Specific Bicarbonate Mixing Procedure,” reviewed 04/2019 indicated documentation must be provided that indicates the test result, the signature of teammate preparing and testing solution, and a verifier signature on the “Bicarb Mixing Log.” Review of the “Bicarbonate Mix Log,” from 06/2024 through 10/2024, indicated the following incomplete documentation: on 06/10/24, a bicarbonate batch was prepared at 08:30 AM, but there was no documentation of the conductivity and the signature of preparer; on 07/31/24, a bicarbonate batch was prepared at 08:30 AM, but there is no documentation of the conductivity, the signature of preparer, and the verification signature; on 08/09/24, a bicarbonate batch was prepared at 04:45 AM but there was no documentation of the conductivity, the signature of preparer, and the verification signature; on 10/02/24, conductivity testing was not performed; on 10/28/24, batch prepared at 04:50 AM, conductivity testing was not performed and there was no verification signature; on 10/28/24, a bicarbonate batch was prepared at 11:55 AM but there was no documentation of the conductivity, the signature of preparer, and the verification signature; and on 10/31/24, there was no documentation of the conductivity and the verification signature. Interview on 11/19/24 at 02:45 PM with Staff (E), Biomedical Technician, verified this finding.”

“BICARB CONC DISTRIB-WKLY DISINFECT/DWELL/CONC CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: weekly disinfection/dwell times/conc Bicarbonate concentrate delivery systems should be disinfected on a regular basis to ensure that the dialysate routinely achieves the level of bacteriological purity [required by these regulations]. For piped distribution systems, the entire system, including patient station ports, should be purged of bicarbonate concentrate before disinfection. Each patient station port should be opened and flushed with disinfectant and then rinsed; otherwise, it would be a “dead leg” in the system. Appropriate dwell times and concentrations should be used as recommended by the manufacturer of the concentrate system. If this information is not available, bleach may be used at a dilution of 1:100 and proprietary disinfectants at the concentration recommended by the manufacturer for disinfecting piping systems. 6.5 Concentrate distribution: The interval between disinfection should not exceed 1 week. If the manufacturer does not supply disinfection procedures, the user must develop and validate a disinfection protocol. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that all points of use (points where bicarbonate solution is utilized) are tested for the presence/absence of chemical disinfectant when the bicarbonate loop (loop containing bicarbonate solution) is disinfected. Findings include: Review of the policy “Bicarbonate Concentrate System Disinfection,” reviewed 10/2023 indicated the verification of chemical presence/absence at all points of use will be documented on the “Bicarbonate Mixer Disinfection Log.” Review of the “Bicarbonate System Bleach Disinfect Log,” from 06/2024 through 10/2024 revealed no evidence that each point of use was tested for the presence/absence of chemical disinfectant when the bicarbonate loop was disinfected every week. Interview on 11/19/24 at 12:30 PM with Staff (E), Biomed Technician, verified there is no documenation of the presence/absence of chemical disinfection when the bicarbonate loop was disinfected every week.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 16136 Based on observation and interview, the facility does not ensure that two of two eye wash stations were unobstructed for use in the event of an emergency. Findings include: Observation on 11/20/24 at 10:00 AM in the water room revealed the eye wash/emergency shower was obstructed by cleaning supplies (squeegee and brooms). At 10:15 AM, the eye wash station across from patient Station #6 was obstructed by a regulated medical waste container. Interview on 11/20/24 at 10:20 AM with Staff (B), Nurse Manager, and Staff (L), Patient Care Technician, verified these observations.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 40430 Based on document review, policy review, observation, and interview, the facility did not ensure the dialysis machine was operated in accordance with the machine manufacturer operating manual and facility policy. Specifically, nursing staff did not ensure the venous bloodline was inserted into the venous line clamp and optical detector prior to machine safety/alarm tests and preparing to initiate patient treatment. Findings include: Review of the “Fresenius Medical Care 2008T Hemodialysis Machine Operator’s Manual-Revision AB,” July 09, 2024 revealed a warning that indicated the tubing (venous line that extends from the machine to the patient to return blood or fluids) beneath the venous drip chamber (level, air and clot detector) must be inserted into the venous line clamp (clamps venous line if air is detected by the optical detector) and optical detector prior to priming (rinsing) the delivery system with normal saline in preparation for machine testing and patient use. Review of the policy “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” revised 04/2024 indicated patient identity, prescription and machine settings are verified by a teammate prior to the initiation of treatment. Review of the policy “Priming a Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Streamline Blood Lines for Subsequent Treatment Shifts” revised 10/2024 indicated after priming the system, staff are to connect both the arterial and venous lines that go to the patient and open the large clamps. Staff are to fill the fluid level in the venous chamber by un-clamping the short tube clamp, then re-clamp when filled. Staff are to place the venous blood line in the metal line clamp of the air detector. This step must be completed to verify that the line clamp is operational during treatment and in an alarm condition. Pressure holding and alarm tests are performed, per procedure. Review of the policy “Treatment Initiation Utilizing Fresenius 2008 Series Dialysis Delivery System with All Single Use Dialyzer Types and Streamline or Combiset or Nipro Blood Lines” revised 10/2024 indicated staff are to verify that the air detector is armed (venous line in air detector line clamp) prior to attaching the venous blood line to the patient and initiating treatment. Observation on 11/18/24 at 10:50 AM at Station #16 revealed the machine was recirculating in “dialysis paused” mode awaiting the arrival of Patient #15. The venous line was not inserted into the venous line clamp and optical detector, per machine manufacturer’s procedure and policy. Interview with Staff (G), Registered Nurse, verified this finding. Observation on 11/18/24 at 10:52 AM at Station #17 revealed Staff (I), Patient Care Technician, cannulated (insert needles) Patient #13’s fistula to initiate their hemodialysis treatment. The machine was recirculating in “dialysis paused” mode, but the venous line not inserted into the venous line clamp/optical detector. Staff (G) verified this finding and inserted the venous line into the venous line clamp and optical detector prior to starting Patient #13’s treatment. Interview on 11/18/24 at 10:55 AM with Staff (F), Facility Administrator, revealed they were notified of the venous line(s) not being inserted into the venous line clamp/optical detector and verified that the venous line should be placed into the clamp/optical detectors before machine safety/alarm tests and prior to preparing to initiate a patient treatment.”

“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: 34528 Based on policy review, observation, medical record review, and interview, nursing staff did not ensure blood flow rates were maintained per physician order, for three of seven patients (Patient #5, Patient #7, Patient #6). Findings include: Review of the policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised 04/2024 revealed if the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate), the reason will be documented, and the licensed nurse will be informed. Review on 11/20/24 of the hemodialysis treatment flowsheets for Patient #5 from 10/25/24 to 11/15/24 revealed the ordered blood flow rate of 400 ml/min was not maintained for one of nine treatments (11/01/24). There was no documentation in the medical record indicating why the blood flow was not maintained. Review on 11/20/24 of the hemodialysis treatment flowsheets for Patient #6 from 10/18/24 to 11/15/24 revealed the ordered blood flow rate of 400 ml/min was not maintained for three of eleven treatments (10/28/24, 11/08/24, 11/15/24). There was no documentation in the medical record indicating why the blood flow was not maintained. Review on 11/20/24 of the hemodialysis treatment flowsheets for Patient #7 from 10/25/24 to 11/15/24 revealed the ordered blood flow rate of 400 ml/min was not maintained for nine of ten treatments (10/25/24, 10/28/24, 10/31/24, 11/01/24, 11/04/24, 11/06/24, 11/11/24, 11/13/24, 11/15/24). There was no documentation in the medical record indicating why the blood flow was not maintained. Interview on 11/20/24 at 10:00 AM with Staff (F), Facility Administrator, verified these findings.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 34528 Based on policy review, medical record review, and interview, the patient care technician did not notify the licensed nurse of abnormal findings for three of seven patients (Patient #3, Patient #5, Patient #7) Findings include: Review of the policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised 04/2024 indicated an intradialytic (during dialysis) systolic (reading of heart contracting) blood pressures (BP) greater than 180 millimeters (mm) of mercury (Hg) or less than 90 mm/Hg and/or a diastolic (reading of heart at rest) blood pressure greater than or equal to 100 mm/Hg or less than 50 mm/Hg, are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Review on 11/18/24 of hemodialysis treatment flowsheets for Patient #3 from 09/30/24 to 11/14/24 revealed a patient care technician documented the following blood pressures (BP): -On 11/15/24 at 07:02 PM, a BP of 201/119; at 07:32 PM, a BP of 176/109; at 08:02 PM, a BP of 182/99; at 09:03 PM, a 188/105; and at 09:16 PM, a BP 219/111. There was no documentation in the medical record that the patient care technician notified the licensed nurse of the abnormal findings/blood pressures. Review on 11/18/24 of hemodialysis treatment flowsheets for Patient #5 from 10/25/24 to 11/15/24 revealed a patient care technician documented the following blood pressures (BP): -On 10/30/24 at 05:31 PM, a BP of 198/107; at 06:01 PM, a BP of 175/113; and at 06:31 PM, a BP of 205/103. -On 11/15/24 at 07:02 PM, a BP of 196/115, at 07:32 PM a BP of 227/122, at 08:02 PM a BP of 232/135, and at 08:05 PM a BP of 230/139. There was no documentation in the medical record that the patient care technician notified the licensed nurse of the abnormal findings/blood pressures on 10/30/24 and 11/15/24. Review on 11/18/24 of hemodialysis treatment flowsheets for Patient #7 from 10/25/24 to 11/15/24 revealed a patient care technician documented the following blood pressures (BP): -On 10/31/24 at 09:33 AM, a BP of 193/81, and at 10:03 AM a BP of 198/80. There was no documentation in the medical record that the patient care technician notified the licensed nurse of the abnormal findings/blood pressures on 10/31/24. Interview on 11/20/24 at 10:00 AM with Staff (F), Facility Administrator, verified these findings.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 40430 Based on policy review, medical record review, and interview, registered nurse pre-treatment assessments were not completed within one hour of treatment for three of five patients (Patient #1, #4, and #5). Lack of assessment has the potential for adverse patient outcomes. Findings include: Review of policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing assessment,” last revised April 2021, indicated the nursing assessment will be performed and documented by a registered nurse within one hour of treatment initiation. Review on 06/03/24 of the treatment flowsheets for Patient #1 dated 04/14/23 to 07/12/23 revealed the following: -On 04/24/23 at 06:48 AM, treatment was initiated by a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 07:57 AM. -On 05/01/23 at 06:25 AM, treatment was initiated by a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 07:48 AM. -On 05/05/23 at 06:06 AM, treatment was initiated by a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 07:20 AM. -On 05/08/23 at 06:21 AM, treatment was initiated a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 08:01 AM. -On 05/12/23 at 06:13 AM, treatment was initiated by a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 09:00 AM. -On 05/15/23 at 06:01 AM, treatment was initiated by a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 07:44 AM. -On 06/09/23 at 06:09 AM, treatment was initiated by a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 07:41 AM. Review on 06/03/24 of the treatment flowsheets for Patient #4 dated 05/20/24 to 05/31/24 revealed on 05/31/24 at 10:59 AM, treatment was initiated by a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 02:48 PM. Review on 06/03/24 of the treatment flowsheets for Patient #5 dated 05/20/24 to 05/31/24 revealed the following: -On 05/20/24 at 11:00 AM, treatment was initiated by a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 12:15 PM. -On 05/24/24 at 10:49 AM, treatment was initiated by a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 01:27 PM. -On 05/29/24 at 10:59 AM, treatment was initiated by a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 12:55 PM. -On 05/31/24 at 11:07 AM, treatment was initiated by a patient care technician, but the registered nurse pre-treatment assessment was not signed off as completed until 12:58 PM. Interview on 06/04/24 at 03:00 PM with Staff (H), Facility Administrator, and Staff (I), Clinical Services Manager, verified these findings.”

“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: 40430 Based on policy review, medical record review, and interview, the registered nurse does not verify the dialysis prescription and/or machine settings for four of five patients (Patient #1, #3, #4, and #5), within 60 minutes of the initiation of treatment. This practice can lead to inadequate dialysis and/or an adverse patient outcome. Findings include: Review of the policy “Treatment Initiation Utilizing Fresenius 2008 Series Dialysis Delivery Systems With All Single Use Dialyzer Types and Streamline, Combiset, or Nipro Blood Lines,” last revised October 2021, indicated staff are to the verify patient prescription (physician orders for a hemodialysis treatment) including, but not limited to: time, target weight, and ultrafiltration (fluid/waste removal) rate and calculate/set the ultrafiltration (rate) per procedure. Review of policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing assessment,” last revised April 2021, indicated the prescription and machine settings are verified by a teammate prior to the initiation of treatment. The prescription components are confirmed by a registered nurse within one hour of treatment initiation. The nursing assessment will be performed and documented by a registered nurse. The nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one hour of treatment initiation. Intradialytic (during) treatment monitoring and data collection which may be performed by a patient care technician or licensed nurse and will include vital signs and treatment monitoring at least every 30 minutes. At a minimum, staff are to obtain and document fluid removal. Review on 06/03/24 of the treatment flowsheets for Patient #1 dated 04/14/23 to 07/12/23 revealed the hemodialysis prescription was not verified by the registered nurse within 60 minutes of the initiation of treatment for 24 of 38 treatments. Examples include: -On 04/14/23 at 05:31 AM, the prescription was verified/signed off by a patient care technician. Treatment was initiated at 06:04 AM by a patient care technician, but the prescription was not verified by the registered nurse until 01:09 PM. -On 05/05/23 at 05:26 AM the prescription was verified/signed off by a patient care technician. Treatment was initiated at 06:06 AM by a patient care technician, but the prescription was not verified by the registered nurse until 09:13 AM. -On 06/19/23 at 06:32 AM the prescription was verified/signed off by a patient care technician. Treatment was initiated at 06:43 AM by a patient care technician, but the prescription was not verified by the registered nurse until 01:33 PM -On 07/03/23 at 05:37 AM the prescription was verified/signed off by a patient care technician. Treatment was initiated at 06:23 AM by a patient care technician, but the prescription was not verified by the registered nurse until 05:40 PM. -On 07/07/23 at 06:27 AM, the treatment prescription was verified/signed off and the treatment was initiated by the patient care technician. At 07:22 AM, the prescription was verified by the registered nurse. Patient #1 had an ordered treatment time of four hours and a target weight of 113.0 kg (used to determine ultrafiltration rate). Patient #1 had a pre-treatment weight of 116.5 kg (3.5 kg above established dry weight). The ultrafiltration rate was set incorrectly to remove 100 ml/hour instead of 1000 ml/hour (to remove 4.0 kg of fluid). Post treatment, nursing staff documented there was a machine setting error due to setting the ultrafiltration rate too low and not removing enough fluid from Patient #1. Patient #1 was placed on an extra two-hour sequential (removes only fluid from the patient) treatment to remove another 3700 ml of fluid for Patient #1 to get down to the ordered dry weight. At 12:30 PM, treatment ended. Interview on 06/03/24 at 10:50 AM Staff (I), Clinical Services Manager, stated if a machine isn’t programmed for enough fluid removal/ultrafiltration goal, it would be considered a treatment error. Interview on 06/04/24 at 10:00 AM, Staff (K), Patient Care Technician, stated they recalled Patient #1 and incident on 07/07/23. The ultrafiltration goal was supposed to be 4000 mls, but they “missed a zero” and only set the machine to remove 400 ml. Staff (K) realized the error before the treatment was completed. Patient #1 was upset because it was a Friday, and their next treatment wouldn’t be until Monday. Patient #1 usually had big fluid gains between treatments, greater than 6000 ml (fluid/waste to be removed). Staff (K) notified the nurse. The patient care technician is supposed to double check the patient dialysis orders/prescription after the treatment is started. The nurse is supposed to double check and verify the orders/goal programmed in the machine. Interview on 06/04/24 at 12:30 PM Staff (J), Registered Nurse stated they recalled the ultrafiltration (fluid/waste removal) goal not being set right on 07/07/23 for Patient #1. When a patient care technician initiates a patient dialysis treatment, the nurse assesses the patient, checks for any concerns, and makes sure that the numbers/orders programmed in the machine are correct within one hour of the start of treatment. Staff (J) stated that they “double checked/verified Patient #1 machine settings/prescription, but it was set for 400ml and not 4000ml. Staff (J) stated that “The numbers were so close I guess I missed it.” Interview on 06/04/24 at 01:30 PM Staff (I), Clinical Services Manager stated that the prescription verification and pre-treatment assessment by the registered nurse are two separate steps/processes that should each be completed within 60 minutes of the initiation of the dialysis treatment. Ultimately, the registered nurse is responsible for prescription verification and making sure all prescribed dialysis parameters/orders or programmed into the machine correctly. Review on 06/03/24 of the treatment flowsheets for Patient #3 dated 05/20/24 at 10:12 AM revealed the prescription was verified/signed off by a patient care technician. At 11:03 AM, treatment was initiated by a patient care technician the prescription was not verified by the registered nurse until 01:41 PM. Review on 06/03/24 of the treatment flowsheets for Patient #4 revealed the following: -On 05/20/24 at 09:35 AM, the prescription was verified/signed off by a patient care technician. Treatment was initiated at 10:40 AM by a patient care technician, but the prescription was not verified by the registered nurse until 01:36 PM. -On 05/22/24 at 10:40 AM, the prescription was verified/signed off by a patient care technician. Treatment was initiated at 10:54 AM by a patient care technician, but the prescription was not verified by the registered nurse until 06:08 PM. -On 05/24/24 at 09:35 AM, the prescription was verified/signed off by a patient care technician. Treatment was initiated at 10:47 AM by a patient care technician, but the prescription was not verified by the registered nurse until 12:39 PM. -On 05/29/24 at 08:21 AM, the prescription was verified/signed off by a patient care technician. Treatment was initiated at 10:41 AM by a patient care technician, but the prescription was not verified by the registered nurse until 01:54 PM -On 05/31/24 at 10:27 AM, the prescription was verified/signed off by a patient care technician. Treatment was initiated at 10:59 AM by a patient care technician, but the prescription was not verified by the registered nurse until 02:48 PM. Review on 06/03/24 of the treatment flowsheets for Patient #5 revealed the following: -On 05/20/24 at 09:25 AM, the prescription was verified/signed off by a patient care technician. Treatment was initiated at 11:00 AM by a patient care technician, but the prescription was not verified by the registered nurse until 12:14 PM. -On 05/24/24 at 10:45 AM, the prescription was verified/signed off by a patient care technician. Treatment was initiated at 10:49 AM by a patient care technician, but the prescription was not verified by the registered nurse until 01:27 PM. -On 05/29/24 at 10:52 AM, the prescription was verified/signed off by a patient care technician. Treatment was initiated at 10:59 AM by a patient care technician, but the prescription was not verified by the registered nurse until 12:55 PM. -On 05/31/24 at 10:57 AM, the prescription was verified/signed off by a patient care technician. Treatment was initiated at 11:07 AM by a patient care technician, but the prescription was not verified by the registered nurse until 12:58 PM. Interview on 06/04/24 at 03:00 PM with Staff (H) Facility Administrator, and Staff (I), Clinical Services Manager verified these findings.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 34528 Based on policy review, document review, and interview, the facility did not ensure all staff completed required annual competencies for two of three staff (Staff (J) and (R). Failure to ensure staff competencies are completed has the potential for inadequate patient care. Findings include: Review of the policy “Teammate Qualifications, Licensure and Adequate Teammate Staffing,” last reviewed 01/31/23 revealed facility teammates (or contractors) will demonstrate competencies necessary to meet the comprehensive needs of the patients annually. Review on 06/04/24 of personnel files for Staff (J) and Staff (R), Registered Nurses revealed no evidence of completing the “2023 Annual Procedural Skills Verification Check List.” Interview on 06/04/24 at 03:00 PM with Staff (I), Clinical Service Manager, verified these findings.”

“MR-COMPLETE RECORDS PROMPTLY CFR(s): 494.170(b)(1) (1) Current medical records and those of discharged patients must be completed promptly. This Standard is not met as evidenced by: 40430 Based on policy review, medical record review, and interview, the facility does not ensure orders are promptly placed in the medical record for one of five patients. (Patient #1). This practice can lead to an inadequate dialysis prescription for patients and an adverse patient outcome. Findings include: Review of policy “Physician Orders for Patient Care,” last revised October 2022, indicated staff are to verify that orders are properly documented, transcribed, verified, and implemented in a timely manner. An order is a diagnostic or therapeutic patient care directive from a facility specific licensed and credentialed practitioner. All orders must be entered into the electronic medical record. Review of the policy “Non-Physician Practitioner Order Policy,” last revised April 2020 indicated verbal orders may only be taken by a licensed nurse teammate authorized to accept physician/provider verbal orders. All orders must be entered into the electronic health record. Review on 06/04/24 of the treatment flowsheet for Patient #1 revealed that on 07/07/23, nursing staff programmed the ultrafiltration (fluid/waste removal) rate on the hemodialysis machine incorrectly to remove 100 ml/hour instead of 1000 ml/hour (to remove 4.0 kg of fluid). Post treatment, nursing documented there was a machine setting error due to staff setting the ultrafiltration rate too low and not removing enough fluid from Patient #1. Patient #1 received an extra two-hour sequential (removes only fluid from the patient) treatment to remove another 3700 ml of fluid to get down to the ordered dry weight (used to determine ultrafiltration weight). At 12:30 PM, treatment ended. (No order for an additional two-hour sequential treatment to remove 3700 ml from Patient #1 was found in the medical record). Interview on 06/04/24 at 11:20 AM Staff (I), Clinical Services Manager, revealed a provider order for an additional two-hour sequential treatment for Patient #1 was not entered into the electronic medical record/treatment orders. Nursing staff received a verbal order from the provider. There should have been a one-time provider order entered for the sequential treatment. Interview on 06/04/24 at 03:00 PM with Staff (H), Facility Administrator, and Staff (I), Clinical Services Manager, verified these findings.”