Davita Southtowns Dialysis

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 34528 Based on policy review, medical record review, document review, and interview, in seven of seven medical records reviewed, 30-minute intradialytic safety checks were not performed to evaluate patients’ vital signs, machine parameters, and access sites, as required (Patient #10, Patient #11, Patient #12, Patient #13, Patient #14, Patient #15, and Patient #16). Reference: 494.180 (b)(1): The governing body or designated person responsible must ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.”

“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: 34528 Based on policy review, observation, and interview, the facility did not ensure staff confirmed all emergency equipment and supplies were immediately available for use and not expired. Findings include: Review of policy “Emergency Equipment Checks” last revised October 2024 revealed equipment checks will be performed by a licensed nurse to verify equipment is available and functional including the emergency cart (code cart) is clean, operational, and all supplies have not expired. Observation on 12/16/24 at 10:30 AM on top of the emergency code cart located in the incenter hemodialysis patient unit revealed the cardiopulmonary resuscitation (CPR) adult pads (applied to an adult to monitor the heart and provide lifesaving electric shocks during a cardiac arrest) connected to the Automatic External Defibrillator (AED-delivers an electrical shock to a person with an abnormal heart rhythm), expired 10/20/24. Interview on 12/20/24 with Staff (K), Regional Coordinator, confirmed these findings.”

“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: 40430 Based on policy review, observation, and interview, the facility does not ensure that staff follow standard infection control practices regarding the use of gloves and hand hygiene. Specifically, staff touch items in the environment/station with and/or without gloves, and do not perform hand hygiene. Findings include: Review of the policy “Infection Control for Dialysis Facilities,” last revised April 2023 indicated all teammates will perform hand hygiene prior to gloving and immediately after the removal of gloves, after patient and dialysis delivery system contact, and before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse. Observation on 12/16/24 at 02:30 PM at Station #3 for Patient #12 revealed Staff (M), Licensed Practical Nurse discontinuing treatment. Staff (M) removed needles from Patient #13’s fistula access, then removed their gloves but did not perform hand hygiene. Staff (M) proceeded to touch the computer mouse on the computer stand between Station #3 and #4 and document in the electronic medical record (EMR). At 2:40 PM, Staff (M) applied a clean glove to their right hand to reset a machine alarm at Station #4 for Patient #26. Staff (M) removed their glove but did not perform hand hygiene before they returned to the computer mouse/computer stand to continue EMR documentation. At 02:45 PM Staff (M) exited the computer stand between Station #3 and Station #4, without performing hand hygiene, and entered Station #10. Staff (M) applied a glove to their right hand to reset a machine alarm and used their ungloved left hand to touch the computer mouse and document in the EMR. Observation on 12/16/24 at 03:18 PM revealed Staff (B), Clinical Coordinator, used their ungloved right hand to pull the handle of the sharp’s container (on wheels) from Station #18 over to Station #12 where Patient #15 was. Without performing hand hygiene, Staff (B) applied clean gloves and proceeded to administer intravenous medications through the hemodialysis machine for Patient #15. Interview on 12/18/24 at 01:00 PM with Staff (K), Regional Coordinator, verified these findings.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 16136 Based on observation and interview, the facility does not ensure staff use the “clean” sink for handwashing and the designated “dirty” sink for contaminated supplies and fluids. Findings include: Observation on 12/16/24 at 10:35 AM to 10:45 AM in the patient care area revealed clean blood clamps and hemostats were located at the dirty sink, across from Stations #3 and #4. Staff (V), Patient Care Technician, emptied the dirty prime bucket fluid in this sink when the clean blood clamps and hemostats were present at this sink. Interview on 12/16/24 at 10:47 AM with Staff (I), Facility Administrator, verified this finding.”

“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 observation, document review, and interview, the facility does not ensure a saturated salt solution exists in at least half of tank for two of two brine tanks (part of the water system that softens and assists in maintaining quality water for hemodialysis). Findings include: Observation on 12/18/24 at 12:35 PM in the water room revealed the salt in the brine tanks for was approximately six (6) inches below the water level. Review of the “2009 Gambro Manufacturer Recommendations,” effective 05/05/09 indicated the manufacturer recommends that the salt level in the brine tanks be maintained at or above the water level to ensure proper operation of these systems. Review on 12/18/24 of the “Reverse Osmosis Daily Water System Log,” from 05/2024 through 11/08/24 revealed the log documented the brine tank salt was at least half full above the water. Interview on 12/18/24 at 12:50 PM with Staff (P), Patient Care Technician, verified this finding.”

“BACT CONTROL DEVICE-UV LIGHT CFR(s): 494.40(a) 5.3.4 Bacterial control devices: 5.3.4.1 Ultraviolet irradiators: UV dose Refer to RD62:2001, 4.3.13 Ultraviolet irradiators: When used to control bacterial proliferation in water storage and distribution systems, UV irradiation devices shall be fitted with a low-pressure mercury lamp that emits light at a wavelength of 254 nm and provides a dose of radiant energy of 30 milliwatt-sec/cm2, [except in the case described below]. The device shall be sized for the maximum anticipated flow rate according to the manufacturer’s instructions. 5.3.4.1 Ultraviolet irradiators If the irradiator includes a meter as described above, the minimum dose of radiant energy should be at least 16 milliwatt-sec/cm2. To prevent the use of sublethal doses of radiation that may lead to the development of resistant strains of bacteria, UV irradiators shall be equipped with a calibrated ultraviolet intensity meter ...or with an on-line monitor of radiant energy output that activates a visible alarm, which indicates that the lamp should be replaced. Alternatively, the lamp should be replaced on a predetermined schedule according to the manufacturer’s instructions to maintain the recommended radiant energy output. 6.3.4 Bacterial control devices 6.3.4.1 Ultraviolet irradiators Ultraviolet irradiators intended for use as a direct means of bacterial control shall be monitored for radiant energy output. UV irradiators should be monitored at the frequency recommended by the manufacturer. A log sheet should be used to indicate that monitoring has been performed. This Standard is not met as evidenced by: 16136 Based on observation, document review, and interview, the facility does not ensure that the ultraviolet (UV) light is maintained (The monitor is used to measure the adequacy of hemodialysis. The UV light transmits a light source through dialysate, to absorb and rid the dialysate of unwanted molecules). Findings include: Observation 12/18/24 at 12:35 PM in the water room revealed the UV monitor/meter reading was 30 %. Review of the document “Gambro Hemodialysis Water Treatment System Operation and Maintenance Manual,” effective 05/05/09 revealed the water system UV light monitor should be greater than 70% during normal use. Interview on 12/18/24 at 01:15 PM with Staff (E), Biomedical Technician, verified this finding.”

“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 failed to provide a safe, functional treatment environment. Specifically, there was no emergency access to one of two patient toilet rooms and an electrical outlet box in the patient care area was not maintained per NFPA 101 - 2012 Edition. Findings include: Observation on 12/16/24 at 11:15 AM revealed emergency access hardware was not provided on one of two patient toilet rooms to ensure immediate access in the event of an emergency. Interview on 12/16/24 at 02:15 PM with Staff (I), Facility Administrator, verified this finding. Observation on 12/16/24 at 03:15 PM in the patient care area revealed an electrical outlet box across from Station #23 had bare wires and was located under the work counter where liquid acid, bicarbonate solution, and paper towels were stored. Interview on 12/16/24 at 03:18 PM with Staff (L), Registered Nurse, verified this finding.”

“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: 16136 Based on document review and staff interview, the facility failed to maintain emergency battery-operated lighting testing, ground fault circuit interrupters, and fire doors to ensure the safety of patients, staff, and the public, per NFPA 101 (2012 Edition). Findings include: Review on 12/17/24 of the “2024 Emergency Lighting Inspection Log,” revealed only 15 of the 24 emergency battery-operated lights located in the facility were tested monthly. Review on 12/17/24 of the “Emergency Light/Exit Signs report,” dated 04/03/24, revealed 90-minute annual testing was not performed on seven of the 24 emergency battery-operated lights. Four of 17 battery-operated emergency lights failed the annual testing. There is no evidence that the battery/ballast were replaced, and the lights retested to ensure proper operation. Review on 12/17/24 of the requested documentation revealed no documentation to verify that the GFCI’s were tested semi-annually or annually according to NFPA 101, 2012 edition. No documentation was received to verify fire doors were tested annually per NFPA 80 - 2012 edition. Interview on 12/17/24 at 01:30 PM with Staff (E), Biomedical Technician, 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 document review, policy review, medical record review, and interview, pre-treatment and catheter assessments were not completed timely by a registered nurse (RN) for three of seven medical records reviewed (Patient #11, Patient #12, and Patient #13), and post-treatment standing blood pressure (BP) assessments were not completed for five of seven medical records reviewed (Patient #10, Patient #11, Patient #12, Patient #14, and Patient #16). Findings include: Review of the policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised April 2024, indicated patient data/vital signs will be documented by the patient care technician (PCT) or a licensed nurse to include standing blood pressure pre and post treatment (if patient unable to stand, document reason in the patient electronic record or flow sheet.) The nursing assessment will be performed and documented by a registered nurse within one hour of dialysis treatment initiation, or sooner, as required by state law. The registered nurse will assess the patient prior to discharge. Review on 12/17/24 of the treatment flowsheets for Patient #10 dated 11/20/24 to 12/16/24 revealed on 11/22/24 and 11/25/24, there is no post-treatment standing BP and/or a reason why a BP could not be obtained. Patient #10’s mobility was documented as ambulatory with no assistance needed. Review on 12/17/24 of the treatment flowsheets for Patient #11 dated 11/20/24 to 12/16/24 revealed a central venous catheter (CVC) access was used to perform hemodialysis. On 11/29/24 and 12/02/24, there is no post-treatment standing BP and/or a reason why a BP could not be obtained. Patient #11’s mobility was documented as ambulatory using assist of a walker. On 12/11/24 at 12:03 PM, treatment was initiated by a licensed practical nurse (LPN), but the RN pre-treatment/catheter assessment was not completed until 01:36 PM. Review on 12/17/24 of the flowsheets for Patient #12 flowsheets dated 11/20/24 to 12/16/24 revealed a fistula access was used to perform hemodialysis. On 11/20/24 and 12/02/24, there was no post-treatment standing BP and/or a reason why a BP could not be obtained. Patient #12’s mobility was documented as ambulatory with no assistance needed. On 12/02/24, treatment was initiated by a PCT at 10:55 AM, but the RN did not complete the RN pre-treatment assessment until 12:48 PM. On 12/04/24, treatment was initiated by an LPN at 10:43 AM, but the RN pre-treatment assessment was not completed until 12:57 PM. On 12/09/24, treatment was initiated by a PCT at 11:14 AM, but the RN pre-treatment assessment was not completed until 01:09 PM. On 12/13/24 treatment was initiated by a PCT at 10:08 AM, but the RN pre-treatment assessment was not completed until 11:42 PM. On 12/16/24 treatment was initiated by a PCT at 11:21 AM, but the RN pre-treatment assessment was not completed until 12:51 PM. Review on 12/17/24 of the treatment flowsheets for Patient #13 dated 11/20/24 to 12/16/24 revealed on 11/29/24, treatment was initiated by a PCT at 11:45 AM, but the RN pre-treatment assessment was not completed until 01:14 PM. Review on 12/17/24 of the treatment flowsheets for Patient #14 dated 11/20/24 to 12/16/24 revealed on 11/22/24, 11/29/24, 12/11/24, and 12/16/24, there is no post treatment standing BP and/or a reason a BP why it could not be obtained. Patient #14’s mobility was documented as ambulatory with cane or walker with no assistance needed. Review on 12/17/24 of the treatment flowsheets for Patient #16 dated 11/20/24 to 12/16/24 revealed on 12/11/24, there is no post-treatment standing BP and/or a reason why a BP could not be obtained. Patient #16’s mobility was documented as ambulatory with no assistance needed. Interview on 12/18/24 at 01:00 PM with Staff (K), Regional Coordinator, verified these findings.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 40430 Based on policy review, medical record review, and interview, the nursing staff did not address the volume status and/or notified the physician related to the target weight for two of six patients reviewed (Patient #10 and Patient #16). Findings include: Review on 12/17/24 of policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised April 2024, indicated the nursing assessment will be performed and documented by a registered nurse (RN) which includes evaluation of volume status. Any abnormal findings, findings outside of any patient specific physician ordered parameters, or if the dialysis prescription is not being met the reason will be documented. The RN will notify the physician as needed of changes in patient status. The following are considered abnormal finding and should be documented in the patient’s medical record: any weight loss from last post weight, and if the patient is above or below 1.0 kilogram (kg) from the target weight (TW-the weight a patient should reach after dialysis treatments to be normally hydrated and comfortable). Review on 12/17/24 of the treatment flowsheets and medical record for Patient #10 dated 11/20/24 to 12/16/24 revealed an ordered target weight of 98 kg. Patient #10 was below their target weight pre and post treatment, for 12 of 12 treatments: -On 11/20/24, the pre-treatment weight was 94.5 kg, and the post-treatment weight was 94.1 kg. The RN pre-treatment assessment note indicated the machine was set to remove no fluid during the treatment due to Patient #10 arriving below their target weight. There was no notification of the physician. -On 11/22/24, the pre-treatment weight was 94.6 kg, and the post-treatment weight was 93.4 kg. The RN pre-treatment assessment documented “set for weight gain,” but does not address Patient #10 arriving below their TW and/or physician notification. -On 11/25/24, the pre-treatment weight was 95.0 kg, and the post-treatment weight was 92.7 kg. There was no documentation in the medical record addressing Patient #10 arriving below their target weight and/or the physician notification. -On 11/27/24, the pre-treatment weight was 93.8 kg, and the post-treatment weight was 92.5 kg. There was no documentation in the medical record addressing Patient #10 arriving below their target weight and/or the physician notification. -On 11/29/24, the pre-treatment weight was 93.8 kg, and the post-treatment weight was 92.6 kg. The RN pre-treatment assessment documented “set for max tolerated uf,” but does not address Patient #10 arriving below their TW and/or physician notification. -On 12/02/24, the pre-treatment weight was 92.2 kg, and the post-treatment weight was 91.5 kg. There was no documentation in the medical record addressing Patient #10 arriving below their target weight and/or the physician notification. -On 12/04/24, the pre-treatment weight was 92.6 kg, and the post-treatment weight was 92.9 kg. There was no documentation in the medical record addressing Patient #10 arriving below their target weight and/or the physician notification. -On 12/06/24, the pre-treatment weight was 93.6 kg, and the post-treatment weight was 91.3 kg. There was no documentation in the medical record addressing Patient #10 arriving below their target weight and/or the physician notification. -On 12/09/24, the pre-treatment weight was 92.9 kg, and the post-treatment weight was 92.2 kg. The RN pre-treatment assessment documented “set for max tolerated uf,” but does not address Patient #10 arriving below their TW and/or physician notification. -On 12/11/24, the pre-treatment weight was 91.8 kg, and the post-treatment weight was 91.5 kg. There was no documentation in the medical record addressing Patient #10 arriving below their target weight and/or the physician notification. -On 12/13/24, the pre-treatment weight was 92.3 kg, and the post-treatment weight was 90.2 kg. There was no documentation in the medical record addressing Patient #10 arriving below their target weight and/or the physician notification. -On 12/16/24, the pre-treatment weight was 91.9 kg, and the post-treatment weight was 90.2 kg. The RN pre-treatment assessment documented “set for last post weight,” but does not address Patient #10 arriving below their target weight and/or the physician notification. Review on 12/17/24 of the treatment flowsheets and medical record for Patient #16 dated 11/20/24 to 12/16/24 revealed an ordered target weight of 69 kg. Patient #16 was below their TW, pre and post treatment for 8 of 10 treatments: -On 11/29/24, the pre-treatment weight was 66.1 kg, and the post-treatment weight was 65.5 kg. The RN pre-treatment assessment note indicated the machine was set to remove “1.0 kg.” There was no documentation in the medical record addressing Patient #16 arriving below their target weight and/or the physician notification. -On 12/02/24, the pre-treatment weight was 66.4 kg, and the post-treatment weight was 65.7 kg. There was no documentation in the medical record addressing Patient #16 arriving below their target weight and/or the physician notification. -On 12/04/24, the pre-treatment weight was 66.8 kg, and the post-treatment weight was 66.1 kg. There was no documentation in the medical record addressing Patient #16 arriving below their target weight and/or the physician notification. -On 12/06/24, the pre-treatment weight was 66.0kg, and the post-treatment weight was 67.1 kg. There was no documentation in the medical record addressing Patient #16 arriving below their target weight and/or the physician notification. -On 12/09/24, the pre-treatment weight was 68.9 kg, and the post-treatment weight was 67.1 kg. The RN pre-treatment assessment note indicated the machine was set to remove “2.0 kg.” There was no documentation in the medical record addressing Patient #16 arriving below their target weight and/or the physician notification. -On 12/11/24, the pre-treatment weight was 67.9 kg, and the post-treatment weight was 66.4 kg. The RN pre-treatment assessment note indicated the machine was set “for target weight.” There was no documentation in the medical record addressing Patient #16 arriving below their target weight and/or the physician notification. -On 12/13/24, the pre-treatment weight was 67.8 kg, and the post-treatment weight was 67.3 kg. There was no documentation in the medical record addressing Patient #16 arriving below their target weight and/or the physician notification. -On 12/16/24, the pre-treatment weight was 67.6 kg, and the post-treatment weight was 67.4 kg. The RN pre-treatment assessment note indicated the machine was set to “challenge target weight.” There was no documentation in the medical record addressing Patient #16 arriving below their target weight and/or the physician notification. Interview on 12/18/24 at 01:00 PM with Staff (K), Regional Coordinator, verified these findings and stated if a patient arrives to treatment three or more times below their prescribed target weight, it is a trend. The patient should be assessed, and the physician notified. A physician order would be required to “challenge” the target weight.”

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 34528 Based on policy review, document review, and interview, the facility does not ensure mortality review of patient deaths is included as a monthly indicator that is analyzed for trends to ensure the quality of the patient care provided. Findings include: Review of the policy “Continuous Quality Improvement Program,” last revised April 2021 revealed the facility will measure, analyze, and track quality indicators. The program must include a mortality review of deaths. Continuous monitoring of the indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. Review on 12/18/24 of the document “Patient Registration Application,” dated 02/17/24 to 06/12/24 revealed Patient #3 expired on 05/06/24, Patient #4 expired 04/17/24, Patient #5 expired 04/02/24, Patient #6 expired 02/17/24, Patient #7 expired 02/20/24, Patient #8 expired 04/24/24, and Patient #9 expired 06/12/24. Review on 12/19/24 of the “Quality Assurance Dashboard,” and the “Quality Meeting Minutes,” from March to July 2024 revealed no documentation of mortality reviews and/or analysis of deaths from February to June 2024. Interview on 12/19/24 at 011:00 AM with Staff (K), Regional Coordinator, verified that the medical director does not conduct mortality reviews of patient deaths.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 34528 Based on policy review, document review, and interview, the facility did not collect quality indicator data related to peritoneal blood pressure and fluid management, for measurement, analysis, tracking, and trending for three of nine months (July, September, and October of 2024). Findings include: Review of the policy “Continuous Quality Improvement Program, “ last revised April 2024 revealed the facility will review measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, indicators as reflected in the “Quality Improvement and Facility Management” meeting minutes. Review on 12/17/24 of the “Peritoneal Dialysis Quality” meeting minutes dated July 2024, September 2024, and October 2024 revealed “Fluid Management” is listed as an indicator. Review on 12/17/24 of the “Peritoneal Treatment Log,” revealed in July 2024, 102 peritoneal dialysis treatments were completed; in October 2024, 108 peritoneal dialysis treatments were completed; and in September 2024, 89 peritoneal dialysis treatments were completed. Review on 12/17/24 of the “Quality Improvement and Facility Management” meeting minutes from February 2024 to October 2024 revealed no evidence that peritoneal blood pressure and fluid management data was collected, measured, analyzed, and tracked for July, September, and October of 2024 for patient peritoneal dialysis treatments. Interview on 12/17/24 at 12:30 PM with Staff (K), Regional Coordinator, confirmed these findings.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 40430 Based on policy review, medical record review, document review, and interview, in seven of seven medical records reviewed, 30-minute intradialytic (during dialysis) safety checks were not performed to evaluate patients’ vital signs, machine parameters, and access sites (Patient #10, Patient #11, Patient #12, Patient #13, Patient #14, Patient #15, and Patient #16). Findings include: Review of the policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised April 2024, revealed that patient data/vital signs will be documented by the patient care technician or a licensed nurse. Intradialytic vital signs and treatment monitoring checks (safety checks) are completed at least every 30 minutes. At minimum, staff are to obtain and document blood pressure, pulse rate, blood and dialysate flow rates, arterial and venous pressures (machine readings to indicate how well or safely the treatment is going), fluid removal and/or replacement, the vascular access (surgical created opening in the skin and blood vessel that allows blood to be removed and returned during hemodialysis) is visible, line connections are intact, and any patient subjective statements and/or complaints. (Vital signs and machine parameters are automatically downloaded from the machine to the electronic medical record flowsheet at a pre-set frequency set by the staff (usually every 30 minutes). Staff must review the information on the machine, the downloaded data in the flowsheet, and observe the patient for each safety check). Review of the “Governing Body Bylaws,” adopted October 04, 2019, indicated the governing body shall ensure compliance by the facility with policies that address completion of medical records and documentation of specific information in such records in compliance with Federal and State laws governing end stage renal disease facilities. Review on 12/18/24 of the treatment flowsheets for Patient #10 from 11/11/24 to 12/16/24 and for Patient #11, #12, #13, #14, #15, and #16 from 10/21/24 to 12/16/24 revealed safety checks for intradialytic vital signs, treatment monitoring, and access visibility/lines intact were not completed every 30-minutes. Many of the safety check entries list “late entry,” had incomplete and/or no patient data collection information. -There were 24 instances where safety checks were not completed for one hour. -There were 15 instances where safety checks were not completed for 1.5 hours. -There were six instances where safety checks were not completed for 2.0 hours. -There were three treatments where safety checks were not completed for 2.5 hours. Interview on 12/18/24 at 09:15 AM with Staff (P) Patient Care Technician, revealed staff were instructed to document “late entry” for safety checks that were missed/or not completed when they are too “busy.” That means staff were not actually at the chairside checking the patient’s vital signs, machine parameter, and access site at the pre-set frequency (usually every 30 minutes). During change over (taking patients off and putting the next shift of patients on the hemodialysis machine), there are a lot of “newer staff.” Staff (P) stated “they don’t always get the chance to complete all patient’s vital signs/treatment monitoring every 30 minutes.” Interview on 12/18/24 at 11:45 AM with Staff (Y), Patient Care Technician revealed if we cannot complete patient checks, we have been instructed to document “late entry.” There are new staff, so we have to pick up more duties until the new staff picked up their speed. In that case 30-minute checks get missed. Interview on 12/18/24 at 01:00 PM with Staff (K), Regional Coordinator, stated missed 30-minute vital signs/treatment monitoring safety checks should be an exception not the rule. Checks should be completed every 30-minutes, as required, for patient safety. Interview on 12/18/24 at 04:45 PM with Staff (L), Registered Nurse, Staff (P), Patient Care Technician, and Staff (V), Patient Care Technician/Administrative Assistant revealed the facility has had recent turnover of staff and there is a lot of newly hired staff. Between answering machine alarms, putting patients on, and taking patients off their treatments, staff are not able to keep up with the 30-minutes safety checks. In that case, we were all instructed to document “late entry” for the checks that were missed. Interview on 12/18/24 at 05:12 PM with Staff (S), Registered Nurse Orientee revealed they were instructed during their orientation to the facility to document “late entry” for checks that were missed, whether it was 30-minutes or one to two hours later. Interview on 12/19/24 at 08:00 PM with Staff (G), Facility Administrator, Staff (I), Facility Administrator, and Staff (K), Regional Coordinator, verified these findings.”