Fmc East Hartford Dialysis Center

“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: 44675 Based on observations, facility documentation, facility policy and interviews, the facility failed to provide a clean and sanitary environment. The findings include: Flash tour observations conducted of the facility treatment floor on 2/26/24 at 9:30 AM identified the following: a. The patient scale non-skid stick surface was peeling off exposing the metal surface b. The chair in Station #11 had a rip on the arm of the chair c. The chair in Station #23 had a rip in the back of the chair d. The chair in Station #23 had a large rip in the back of the chair e. Observation conducted on 2/26/24 at 2:53 PM identified Staff Member #1 was wearing gloves, a gown, and face shield into the lobby while wheeling out a patient in a wheelchair. f. Observation conducted on 2/26/24 at 2:56 PM identified Staff Member #2 was wearing glove, a gown, and face shield into the lobby while walking a patient out. Interview with the Clinical Director on 2/28/24 at 1:00 PM identified staff members were utilizing personal protective equipment (PPE) in the lobby with patients during COVID-19 outbreak. However, he was unable to provide updated guidance if PPE remained acceptable in the lobby. Review of the General Cleanliness and Infection Control Guidelines policy identified the purpose of the policy is to provide guidance on preventing the spread of infectious disease and maintaining a clean, safe, aesthetically pleasant environment for patients, staff and visitors. It further identified all areas must be kept clean and organized, including but not limited to the treatment area, water/supply room and offices.”

“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: 32738 Based on observations, facility policy, and interviews, two (2) of four (4) patients that received hemodialysis treatment the facility failed to ensure hand hygiene was performed by patients prior to leaving the treatment floor after hemodialysis treatment. The findings include: a. Observation on 2/28/24 at 9:55 AM identified that Patient # 18 was holding/h/her dialysis access site with the left gloved hand. The resident went to the scale and weighed him/herself and then left the treatment floor without hand hygiene or reminders from staff to perform hand hygiene. b. Observation on 2/28/24 at 10:05 AM identified Patient #19 completed hemodialysis treatment, was assisted into the wheelchair and brought to the lobby by a staff member without performing hand or reminders form staff to perform hand hygiene. Based on observations and review of facility policy, the facility failed to perform hand hygiene between tasks which created the potential of exposing patients and staff to contaminated medical equipment, infectious substances and the transmission of infectious diseases. The findings included: (Meg, I changed the letters in front of the observations to coincide with Jackie’s tag) c. Observation on 2/28/24 from 9:59 AM to 10:03 AM identified Staff Person #5 failed to perform hand hygiene twice following glove removal during cleaning/disinfecting the hemodialysis machine at Station #8. d. Observation on 2/28/24 at 10:13 AM identified Staff Person #5 failed to offer Patient #17 at Station # 7 hand sanitizer after he/she removed his/her glove after holding his/her access site. Review of the Personal Protective Equipment policy dated 11/6/23 directed to always perform hand hygiene after glove removal.”

“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: 32738 Based on observations, and policy review, the facility failed to ensure adequate disinfection of the dialysis station in between patient use. The findings include: a) Observation on 2/28/24 at 9:55 AM of the disinfection of station # 21 identified that the sharps box was not disinfected although part of the dialysis station. b) Observations on 2/28/24 at 10:00 AM of the disinfection of station # 23 identified that the sharps box was not disninfected although part of the dialysis station. c) Observation during the disinfection of Station #8 on 2/28/24 at 10:03 AM identified Staff Person #5 failed to disinfect the tubing attached to the acid and bicarbonate connectors in front of the machine and the area of the machine under the tubing, the top of the intravenous pole, the sharps container, the blood pressure cuff cage, the side of the hemodialysis machine the sharps container was attached to, arm of the television, and back counter. Furthermore, Staff Person #5 placed a clean blood pressure cuff into the cage that was not disinfected. Review of the cleaning and disinfection the dialysis station policy directed the dialysis station includes the dialysis machine, attachments such as IV pole, BP cuff, hand sanitizer, organizer and bed. It directed after use, any non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach or EPA registered disinfectant.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 32738 Based on clinical record review, facility documentation, and interviews, for one (1) of three (3) patients reviewed for Hepatitis B vaccination (Patient #6), the facility failed to ensure that the vaccination series for Hepatitis B was given in accordance with facility procedure. The findings include: Patient #6 had a diagnosis of end stage renal disease and required hemodialysis three times weekly. Review of the hepatitis B summary report for Patient #6 identified that on 10/12/23 the patients antibody levels were below 10, indicating that the patient is susceptible to the hepatitis B virus. Review of the immunization record identified that the first vaccination was given on 11/11/2023, and the second vaccination was not given until 2/8/23 ( almost three months after the first vaccination). Interview with the facility administrator on 2/27/24 at 1:45 PM identified that the facility does not have a policy on Hepatitis vaccination, but the procedure is to administer the vaccination as soon as it is determined the patient is susceptible, and then the second dose is given 1 month after that and the third dose is give a month after that and the 4th dose is given 6 months after the first dose. The FA identified that the series should have been started over when the second dose was given almost 3 months late.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 47491 Based on observation, interview, and review of facility policy, the facility failed to clean the diaphragm of a multi-use vial each time the vial was entered with a new needle and based on observation and review of medications in one of two facility medication carts, the facility failed to dispose of expired medications. a. Observation and interview with Staff Person #4 on 2/27/24 at 9:13 AM identified Staff Person #4 drawing up several doses of heparin without first cleaning the diaphragm of the heparin bottle with a new alcohol prep pad prior to inserting each new needle into the bottle. Interview with Staff Person #4 indicated he/she cleans the diaphragm of the heparin bottle only once prior to making several withdrawals. Review of the Medication Preparation and Administration policy dated 2/6/23 directed to clean the diaphragm of a multi-use vial with a new alcohol pad each time the vial is accessed with a needle, using friction and 70% alcohol and allow to dry before inserting a device into the vial.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 47491 Based on observation, interviews, and policy review, the facility failed to ensure proper face mask placement when performing Central Venous Catheter exit site care, (Patient #15) and two patients who had a central venous catheter (CVC) for hemodialysis access (Patient #15 and Patient #16), the facility failed to disinfect the CVCs in accordance with the facility policy. The findings included: 1. Patient #15 had a diagnosis of end stage renal disease, dependence on renal dialysis, required dialysis treatment three times weekly, and had a central venous catheter (CVC) tunneled into his/her upper chest. a. Observation of Staff Person #1 on 2/26/24 at 9:48 AM identified Patient #15 receiving CVC exit site care prior to treatment initiation. Staff Person #1 had removed Patient #15’s CVC dressing, changed his/her gloves, performed hand hygiene, and proceeded to cleanse the site, however, Staff Person #1 failed to ensure Patient #15’s mask was applied properly, completely covering both his/her nostrils during exit site care. Interview with Staff Person #1 on 2/26/24 at 10:13 AM indicated Patient #15’s mask kept sliding down during exit site care because he/she was talking throughout the procedure. A follow-up interview with Staff Person #1 on 2/28/24 at 9:13 AM identified it was the nurse’s responsibility to ensure Patient #15’s mask was applied properly, with both nostrils covered, throughout the exit site care process. Review of the Changing the Catheter Dressing Procedure dated 2/5/24 directed the patient and care partner must wear a mask for all procedures that require accessing the catheter and to apply a mask to the patient and caregiver to prevent contamination by airborne nasal bacteria. b. Observation of Patient #15 on 2/26/24 at 9:50 AM identified Staff Person #1 providing CVC care prior to hemodialysis treatment. Staff Person #1 had removed the cap from both the arterial and venous limbs of the CVC to disinfect the hubs (ends of the catheter limbs) utilizing an alcohol preparation pad for a minimum of fifteen seconds per hub. Staff Person #1 then attached a sterile syringe to each hub to withdraw blood from the CVC, to administered heparin into the venous line, connected lines to each hub, and initiated treatment without cleaning the limbs of the catheter. Interview with Staff Person #1 on 2/26/24 at 10:12 AM indicated he/she only scrubs the hubs (uncovered ends) of the catheter prior to initiating treatment and that policy indicated to only scrub the uncovered ends with an alcohol prep pad prior to initiating treatment. 2) Patient #16 had diagnoses of end stage renal disease, required hemodialysis three times weekly, and had a CVC tunneled into the upper chest region. Observation of Patient #16 on 2/26/24 at 10:00 AM identified Staff Person #2 providing CVC care prior to hemodialysis treatment. Staff Person #2 had removed the cap from both the arterial and venous limbs of the CVC to disinfect the hubs (ends of the catheter limbs) utilizing an alcohol preparation pad for a minimum of fifteen seconds per hub. Staff Person #2 then attached a sterile syringe to each hub to withdraw blood from the CVC, administered heparin into the venous line, connected lines to each hub, and initiated treatment without cleaning the limbs of the catheter. Interview with Staff Person #2 on 2/26/24 at 10:14 AM indicated he/she only scrubs the hubs (uncovered ends) of the catheter prior to initiating treatment and that policy indicated to only scrub the uncovered ends with an alcohol prep pad prior to initiating treatment. Review of the Initiation of Treatment Using a CVC policy dated 7/6/2021 directed to use the same sterile alcohol pad to clean the hub(s) and limb(s) of the CVC, scrubbing from the hub at least several centimeters towards the body of the catheter.”

“MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ CFR(s): 494.40(a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1. 7.2.2 Sample collection Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers. This Standard is not met as evidenced by: 44675 Based on observations, facility documentation, facility policy and interviews for Patient #1, reviewed for cardiac arrest, the facility failed to obtain and assess dialysate cultures after a cardiac event during treatment per facility policy. The findings include: Patient #1 was admitted to the facility with diagnoses that included end stage renal disease. Patient #1’s physician orders included hemodialysis treatment three times a week for three hours and fifteen minutes, 2.0 K 2.5 Ca dialysate, estimated dry weight (EDW) of 82.5 kg and blood flow rate of 450. Review of the dialysate cultures for machine #7T0S215011 identified the machine was last cultured on 11/29/22 and the colony count was <2 (acceptable) and endotoxin count was <0.01 (acceptable). Review of Patient #1’s hemodialysis treatment sheet dated 4/6/23 identified Patient #1 began treatment at 2:52 PM and at 6:06 PM Patient #1 was notified to be unresponsive, CPR was initiated and 911 was called. A nursing note dated 4/6/243 at 7:16 PM identified Patient #1 was noticed to be unresponsive at the end of treatment, CPR was initiated on acknowledgement of no pulse at 6:00 PM and an external automatic defibrillator (AED) was applied at 6:06 PM. One shock was advised and applied at 6:06 PM, CPR was continued and no shocks were advised. 911 was called at 6:12 PM, arrived at 6:15 PM, CPR was taken over by EMT and Patient #1 was transported to the hospital. Water samples were collected and the machine was pulled from service. The Medical Director, Facility Administrator, CN and Area Technical Operations Manager were notified. Review of the functional test of dialysis machine following adverse clinic event dated 4/7/23 identified the following were within parameters for machine 7T0S215011; conductivity and pH of dialysate at time of event, temperature of machine used, UF controls were functioning properly, audible alarms could clearly be heard and pre-treatment check. The form failed to identify if dialysate cultures were drawn. The form failed to identify the first page regarding the dialysis machine parameters were completed. Interview with the Biomedical Technician on 2/27/24 at 10:00 AM identified he did not test dialysate samples after the cardiac arrest that occurred during treatment on 4/6/23. He further identified he does not collect dialysate samples following an adverse event and that he only completed the Functional Test of the Dialysis Machine Following an Adverse Event page two and indicated clinical staff are to complete the first page. Interview with the Regional Biomedical Manager on 2/27/24 at 12:50 PM identified dialysate cultures should be drawn after a cardiac event. He further identified it is up to the dialysis nursing staff at the time of the event to collect the samples of the dialysate used during that treatment to give to the biomedical technician. Interview with the FA on 2/27/24 at 1:03 PM identified she was unable to produce the first page of the device evaluation following patient event form. Review of the guidelines for staff response during cardiopulmonary arrest policy directed when a cardiopulmonary arrest occurs during treatment, the machine will be visually inspected for the presence of kinks, twists, inappropriately placed clamps, tears, cuts or leaks in the extracorporeal circuit. The machine will be removed from the treatment area, collect dialysate sample for any concentrates used, tag the machine and have the machine tested by the biomedical staff. Review of the device evaluation following patient event policy directed the facility technical staff and clinic staff will complete a device evaluation following patient event form. It further directed trained staff will collect dialysate specimens and send to the laboratory for both colony count and LAL analysis as soon as practical following a patient event.”

“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: 17921 Based on review of facility documentation, and interview of facility staff, the facility failed to ensure that 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. The findings include: Documentation was not provided by the Area Technical Operations Manager to indicate that the automatic sprinkler system had been inspected on a quarterly basis during the past twelve (12) months by an authorized service company as required by NFPA 25, “Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems”. i.e. the second quarter inspection reports for 2023 was not provided.”

“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: 44675 Based on review of clinical records, interview, and policy review for two (2) of three (3) hemodialysis patients reviewed for blood pressures (Patient #2, and #10, ), the facility failed to ensure a licensed nurse was notified of a patient’s decrease in Blood Pressure (BP) during treatment, and for one (1) of three (3) patients reviewed for fluid balance,(Patient #7) the facility failed to address the patient leaving the facility above the estimated dry weight resulting in subsequent hospitalizations for fluid overload. The findings include the following: 1) Patient #7 had a diagnosis of end stage renal disease that required hemodialysis three times weekly for three hours and fifteen minutes with a 2.0 K 2.5 Ca dialysate with a blood flow rate of 475., with an Estimated Dry Weight (EDW) of 55 kg. a) Review of a treatment sheet dated 2/2/24 identified the patients post weight was noted to be 61.3 kg (6.3 kg above the EDW), the patient accepted a 2 hour ultrafiltration treatment on 2/3/24. The patient did not come to scheduled treatment on 2/5/24. The patient came to treatment on 2/7/24 with a pre-weight of 67.3, and a post weight of 66 kg (10 kg over the EDW), the clinical record failed to identify any interventions to address the patient leaving significantly over the EDW. The resident did not come to treatment on 2/9/24 or 2/12/24. Review of a hospital discharge summary dated 2/12/24 identified that the resident was admitted to the hospital on 2/9/24 for respiratory failure due to pulmonary edema cause by fluid volume overload. b) Review of a treatment sheets 2/16 and 2/19/24 identified that the patient had dialysis treatments, however was a no show on 2/21/24. On 2/23/24 the hemodialysis pre-treatment weight was 68.4 kg and the post weight was 67.0 kg (12 kg over the EDW), the clinical record failed to identify any interventions offered to address the patient leaving significantly over the EDW. The patient was a no show for treatment on 2/26/24. Review of a hospital discharge summary dated 2/27/24 identified that the patient was admitted on 2/26/24 with fluid overload. Interview with the facility administrator on 2/27/24 at 1:25 PM identified that the resident has significant issues with treatment compliance. The facility should have addressed the patient leaving significantly over the EDW on 2/7 and 2/23/24 such ass offering an extra treatment or contacting the physician. 2) Patient #2 had diagnoses that included end stage renal disease. Patient #2’s physician orders included hemodialysis treatment three times a week for three hours and thirty minutes, 2.0 K 2.5 Ca dialysate, estimated dry weight (EDW) of 71 kg and blood flow rate of 450. Review of Patient #2’s hemodialysis flowsheets identified the following: a. On 1/26/24 Patient #2 started hemodialysis treatment at 10:23 AM by Staff Member #2, a Patient Care Technician (PCT) at 11:01 AM Patient #2’s BP was 106/68 and at 11:36 AM the BP decreased to 75/42. At 11:37 AM, Patient #2’s blood pressure was 81/47 and Staff Member #2 decreased Patient #2’s machine temperature and decreased the goal by 200 milliliters (ml). At 11:45 AM Patient #2’s blood pressure was 88/51 and Staff Person #2 decreased Patient #2’s goal by 100 ml. The record failed to identify that the registered nurse was notified of Patient #2’s blood pressure below 100 systolic and directed the interventions that a non-licensed staff member preformed. Patient #2 ended treatment at 1:51 PM. Patient #2’s post treatment assessed at 2:29 PM identified Patient #2 had a stable treatment with no complaints. The post-treatment assessment failed to follow up on Patient #2’s hypotension during treatment. b. On 1/31/24 Patient #2 started hemodialysis treatment at 10:12 AM by Staff Member #2, PCT. At 11:01 AM Patient #2’s BP was 99/56 Staff Member #2 decreased Patient #2’s machine temperature and decreased the goal by 100 ml. The record failed to identify that the registered nurse was notified of Patient #2’s blood pressure below 100 systolic and directed the interventions that a non-licensed staff member preformed. Patient #2 ended treatment at 1:41 PM. Patient #2’s medical record failed to identify Patient #2 had a nursing assessment completed for treatment and follow up on Patient #2’s hypotension during treatment. Interview with the Clinical Coordinator on 2/26/24 at 3:18 PM identified if a patient’s blood pressure is less than 100 systolic, an intervention should be done unless there is a special attention order in the patient’s physician orders to continue hemodialysis at a specific blood pressure ordered. Interview with the Clinical Services Director on 2/27/24 at 1:09 PM identified if a patient’s blood pressure is less than 100, it should be rechecked and the RN should be notified. He identified non-licensed staff need to consult with the nurse before lowing a patient’s goal. He further identified during record review, the nursing notes failed to identify nursing was aware of Patient #2’s hypotension during treatment on 1/26/24 and 1/31/24 3. Patient #10 was diagnosed with end stage renal disease, required hemodialysis three times weekly, and had a tunneled central venous catheter (CVC) in the upper chest. Review of Patient #10’s clinical record identified: a)Patient #10’s blood pressure at treatment initiation on 2/10/24 was 112/70, then at 8:02 AM (88/54), 150 ml of NS given at 8:06 AM, 8:06 AM (81/52), 8:18 AM (90/55), 8:32 AM (89/53), 8:46 AM (79/53), 200 ml of NS given at 8:47 AM, 9:03 AM (90/61), and 9:33 AM (88/53). Review of the electronic medical record failed to indicate the charge nurse was informed of Patient #10’s low blood pressure readings during his/her 2/10/24 treatment. b) Review of during treatment on 2/20/24 (80/52 at 8:07 AM, 92/58 at 8:34 AM, and 88/52 at 9:43 AM). Review of the electronic medical record failed to indicate the charge nurse was informed of Patient #10’s low blood pressure readings during treatment on 2/20/24. Interview with the Clinical Director of Operations on 2/28/24 at 1:43 PM identified the expectation that staff follow clinic policies related to nurse communication and involvement when a patient has low blood pressure readings. Review of the nursing supervision and delegation policy directed the PCT/LPN or RN should refer a patient to the Charge Nurse for further assessment pre, during or post treatment if a patient’s blood pressure is less than or equal to 100 mm/hg systolic during treatment. It further directed prior to discharge the RN must review the treatment record to confirm the patient is stable for discharge, low or high blood pressures and blood pressures <100 systolic addressed by the registered nurse with or documentation present. Review of the hypotension policy directed the LPN/PCT must immediately report signs and symptoms of hypotension to the RN/Supervising RN.”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 44675 Based on review of clinical records, interview, and policy review for two (2) of three (3) hemodialysis patients reviewed for anemia (Patient #7 and #8), the facility failed to ensure a drop in the patients hemoglobin was addressed, and hemoglobin levels were drawn in accordance with physician orders. The findings include the following: 1. Patient #7 had a diagnosis of end stage renal disease that required hemodialysis three times weekly for three hours and fifteen minutes with a 2.0 K 2.5 Ca dialysate with a blood flow rate of 475. a) Review of physician’s orders directed to obtain a hemoglobin level weekly. Review of hemoglobin levels identified that the patient had hemoglobin levels drawn on 12/20, 12/27/23, 1/3, 1/12. and 1/31/24. A hemoglobin level was missed between 1/12 and 1/31/24 (19 days in between hemoglobin draws). Interview with the facility administrator on 2/27/24 at 2:00 PM identified that the patient attended treatment on 1/21/24 and the hemoglobin level should have been drawon on that date. b) Review of hemoglobin levels on 1/3/24 identified a level of 8.0 ( 10-12 is the range for ESRD patients), the next hemoglobin level was drawn on 1/12/24 and resulted at 6.8, the clinical record failed to identify that the drop of hemoglobin was reported to the physician. Interview with the Clinical Coordinator on 2/27/24 at 2:05 PM identified that her usual practice is to notify the physician is a hemoglobin level drops below 8, however she did not. Interview with the medical director on 2/27/24 at 11:30 AM identified that he would expect notification of a hemoglobin level of 6.8 and most likely would have ordered a repeat level to ensure accuracy. 2. Patient #8 was admitted to the facility with diagnoses that included end stage renal disease. Patient #8’s physician orders included hemodialysis treatment three times a week for three hours and thirty minutes, 3.0 K 2.5 Ca dialysate, estimated dry weight (EDW) of 86 kg and blood flow rate of 400. Patient #8’s hemoglobin on 1/4/24 was 12.9, on 1/11/24 was 8.8 (4.1 drop in one week). Review of the Mircera protocol identified Patient #8 was last administered Mircera 100 mcg on 12/19/23. The Mircera was on hold at the time of the lab draw and on 1/13/24 60 mcg every two weeks was ordered per the protocol. On 1/16/24 Patient #8 was administered 60 mcg Mircera Review of Patient #8’s progress notes failed to address Patient #8’s hemoglobin decreased of 4.1 points in one week was reported to the physician. Interview with the Clinical Coordinator on 2/27/24 at 1:06 PM identified she could not find any documentation regarding Patient #8’s drop in hemoglobin and interventions provided. She further identified she would expect the physician to be notified of a hemoglobin drop of 4.1 over one week. Review of the Mircera algorithm directed to consult the physician for the following during a non-dosing week if there has been a minimum of 14 days since the last dose change and the hemoglobin is less than 8.0 or the hemoglobin decreased by more than 1.0 over the past two weeks and Mircera dose is currently not on hold or the hemoglobin is less than 10.5 and decreasing over the past two weeks.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 32738 Based on clinical record review, facility documentation, and interviews, for one (1) one of three (3) patients reviewed for hospitalizations, (Patient #7), the facility failed to assess the patients stability after several hospitalizations. The findings include: Patient #7 had a diagnosis of end stage renal disease that required hemodialysis three times weekly for three hours and fifteen minutes with a 2.0 K 2.5 Ca dialysate with a blood flow rate of 475., with an Estimated Dry Weight (EDW) of 55 kg. The resident’s last care plan was deemed stable and was completed on 4/26/23. Review of the clinical record identified that Patient #7 was hospitalized from 7/23-7/26/23, 8/2-8/7/23, and 8/7-8/10/23, three hospitalizations within 30 days. The clinical record further identified that patient was hospitalized from 8/21-9/1/23, 9/10-9/15/23 and 9/20-9/24/23, three hospitalizations within a 30 day period. Interview with the Facility Administrator on 2/27/24 at 10:30 AM denitrified that the patient should have been assessed for stability with the first and second episodes of hospitalizations, however it was not done. Review of the comprehensive care plan policy identified that if the patient has three hospital admissions within 30 days an assessment must be completed to determine stability.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 44675 Based on observations, facility documentation, facility policy and interviews, the facility failed to discard of expired medications, complete nursing assessments (Patient #1 and Patient #2), measure and document vital signs every thirty minutes ( (Patient #2 and Patient #3), ensure interventions were in place for a patient who had shortened treatment times (Patient #13), and the facility failed to ensure staffing was adequate to ensure all patients received hemodialysis in accordance with physician’s orders. The findings include: 1. a. Review of the monthly emergency code cart and medication checklist dated 1/1/24 identified there were two dextrose 50% vials with an expiration dated of 2/1/24. Observations conducted during the flash tour on 2/26/24 at 9:45 AM identified two vials of sodium bicarbonate 50 mcg/50 ml with an expiration date of 2/1/24 and two vials for 50% dextrose 25 g/50 ml with an expiration date of 2/1/24 in the crash cart on the treatment floor. Observations conducted on 2/27/24 at 10:00 AM identified the four expired medications remained in the crash cart on the treatment floor. b. Observation on 2/26/24 at 9:30 AM identified two boxes of 50% Dextrose Injections Ansyr II with an expiration date of 2/1/24 were located in the bottom drawer of the medication cart located next to the nurse’s station. Interview with the Clinical Coordinator on 2/26/24 at 10:18 AM identified it was the responsibility of the charge nurse to discard expired medications, was unsure as to why the expired medications were disposed of, and ensured the expired medications would be discarded. Observation and interview with the Clinical Coordinator on 2/27/24 at 9:10 AM identified both boxes of 50% Dextrose Injections Ansyr II with an expiration date of 2/1/24 were still located in the bottom drawer of the medication cart next to the nurse’s station. Observation on 2/28/24 at 9:00 AM identified the expired medications were no longer located in the bottom drawer of the medication cart next to the nurse’s station. Review of the Medication Preparation and Administration policy dated 2/6/23 directed expired medications were to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law. 2. a. Patient #1 was admitted to the facility with diagnoses that included end stage renal disease. Patient #1’s physician orders included hemodialysis treatment three times a week for three hours and fifteen minutes, 2.0 K 2.5 Ca dialysate, estimated dry weight (EDW) of 82.5 kg and blood flow rate of 450. Review of Patient #1’s hemodialysis flowsheets identified on 1/26/24 Patient #2 started hemodialysis treatment at 2:52 AM and ended treatment at 6:09 PM due to adverse occurrence. Patient #2’s pre-treatment assessment was completed at 7:03 PM (3 hours treatment initiation and 1 hour after treatment was discontinued). b. Patient #2 was admitted to the facility with diagnoses that included end stage renal disease. Patient #2’s physician orders included hemodialysis treatment three times a week for three hours and thirty minutes, 2.0 K 2.5 Ca dialysate, estimated dry weight (EDW) of 71 kg and blood flow rate of 450. Review of Patient #2’s hemodialysis flowsheets identified on 1/26/24 Patient #2 started hemodialysis treatment at 10:23 AM by Staff Member #2, a Patient Care Technician (PCT) and ended treatment at 1:51 PM. Patient #2’s pre-treatment assessment was completed at 1:23 PM (3 hours after treatment initiation) by Staff Member #4 (RN). On 1/31/24 Patient #2 started hemodialysis treatment at 10:12 AM by Staff Member #2, PCT and ended treatment at 1:41 PM. Patient #2’s medical record failed to identify a nursing assessment was completed for Patient #2’s treatment. Review of Patient #2’s progress notes failed to identify a nursing assessment was documented for 1/26/24 and 1/31/24. Review of the nursing supervision and delegation policy directed the registered nurse is to perform an assessment of each patient preferably within an hour (or according to state requirements) of treatment initiation in the clinic setting. 3. a. Patient #2 was admitted to the facility with diagnoses that included end stage renal disease. Patient #2’s physician orders included hemodialysis treatment three times a week for three hours and thirty minutes, 2.0 K 2.5 Ca dialysate, estimated dry weight (EDW) of 71 kg and blood flow rate of 450. Review of Patient #2’s hemodialysis flowsheets identified the following: aa. On 2/2/24 Patient #2’s vital signs were obtained at 10:28 AM then 11:33 AM (1 hour and 5 minutes later). Patient #2 experienced a blood pressure decrease of 62 points systolic. bb. On 2/5/24 Patient #2’s vital signs were obtained at 11:06 AM then 12:04 PM (58 minutes later). cc. On 2/7/24 Patient #2’s vital signs were obtained at 12:35 PM then 1:37 PM (1 hour and 2 minutes later). dd. On 2/14/24 Patient #2’s vital signs were obtained at 12:15 PM then at the end of treatment at 1:54 PM (1 hour and 39 minutes later). ee. On 2/16/24 Patient #2’s vital signs were obtained at 11:06 AM then 12:05 PM (1 hour and 4 minutes later). b. Patient #3 was admitted to the facility with diagnoses that included end stage renal disease. Patient #3’s physician orders included hemodialysis treatment three times a week for four hours, 2.0 K 2.5 Ca dialysate, estimated dry weight (EDW) of 63.5 kg and blood flow rate of 400. Review of Patient #3’s hemodialysis flowsheets identified the following: ff. On 2/7/24 Patient #3’s vital signs were obtained at 1:34 PM then 2:33 PM (59 minutes later). gg. On 2/9/24 Patient #3’s vital signs were obtained at 1:35 PM then 2:31 PM (56 minutes later). hh. On 2/16/24 Patient #3’s vital signs were obtained at 11:32 AM then 12:33 PM (1 hour and 1 minute later). i. On 2/23/24 Patient #3’s vital signs were obtained at 10:57 AM then 12:35 PM (1 hour and 38 minutes later) and then at 1:41 PM (1 hour and 6 minutes later). Review of the patient assessment and monitoring policy directed to obtain blood pressure and pulse rate every thirty minutes or more as needed but not to exceed forty five minutes or per state regulation. Review of the hypotension policy directed to monitor and document blood pressure every thirty minutes unless deemed more frequent by patient condition. 4. Patient #13 was admitted to the facility with diagnoses that included end stage renal disease. Patient #13’s physician orders included hemodialysis treatment three times a week for three hours and thirty minutes, 2.0 K 2.5 Ca dialysate, estimated dry weight (EDW) of 80 kg and blood flow rate of 450. Review of Patient #13’s hemodialysis treatment sheets identified the following: a. On 2/14/24 Patient #13 received 2 hours and 35 minutes of treatment (decreased by 55 minutes due to late arrival with in inability to extend treatment). b. On 2/22/24 Patient #13 received 2 hours and 52 minutes of treatment (decreased by 38 minutes due to late arrival with in inability to extend treatment). c. On 2/27/24 Patient #13 received 3 hours and 2 minutes of treatment (decreased by 28 minutes due to late arrival with in inability to extend treatment). Review of Patient #13’s nursing notes failed to identify the physician was notified that Patient #13 did not receive their full prescribed treatment on 2/14/24, 2/22/24 and 2/27/24 and interventions, if any). Interview with the Facility Administrator on 2/28/24 at 11:47 AM identified against medical advice (AMA) forms are not completed for treatment time that is decreased due to a patient’s late arrival. Review of the early termination or arriving late for treatment policy directed if a patient arrives late staff should do their best to accommodate the patient’s prescribed treatment time. If it is not possible due to all stations being filled or impacting facility hours of operation, the physician must be notified to review the time delay and determine the appropriate intervention. 5. Review of the master schedule for pod 1 first shift on 3/3/23 identified that there were four (4) patients scheduled to dialyze, the first starting at 6:00 AM. The schedule further identified that a R/S was notated beside the patient names. Interview with the Facility Administrator (FA) on 2/29/24 at 1:46 PM identified that there was a call out for that pod, however, she could not recall when the call out had come in. They had called all staff to come in and had no success for someone to come in at 6:00 AM, however, a staff member had agreed to come in at 8:30 AM. The FA identified that 3 patients were re-scheduled (R/S), for the next day, but one patient was unable to be reached to re-schedule so the treatment for 3/3/23 was missed.”

“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: 47491 Based on review of clinical records, interviews, and facility policy for one (1) of fourteen (14) patients reviewed (Patient #10), the facility failed to ensure patient assessments and monitoring were performed per policy. Patient #10 was diagnosed with end stage renal disease, required hemodialysis three times weekly, and had a tunneled central venous catheter (CVC) in the upper chest. Review of Patient #10’s clinical record identified: Initial assessments were entered into the patient chart greater than one hour following treatment initiation on 2/3/24 (6 hours and 20 minutes following treatment initiation), 2/10/24 (3 hours and 43 minutes after treatment initiation), 2/13/24 (3 hours and 36 minutes after treatment initiation), 2/15/24 (3 hours and 27 minutes after treatment initiation), 2/17/24 (2 hours and 49 minutes after treatment initiation), and 2/22/24 (2 hours and 4 minutes after treatment initiation). Interview with the Clinical Director of Operations on 2/28/24 at 1:43 PM identified the expectation that staff follow clinic policies related to the timely entry of patient assessments into the electronic medical record. Review of the Nursing Supervision and Delegation policy dated 11/6/23 directed the registered nurse must evaluate each patient preferably within an hour (or according to state requirements) of treatment initiation.”

“MR-MAINTAIN HOME PT RECORDS CFR(s): 494.170(b)(3) (3) The dialysis facility must complete, maintain, and monitor home care patients’ records, including the records of patients who receive supplies and equipment from a durable medical equipment supplier. This Standard is not met as evidenced by: 47491 Based on review of clinical records, interviews, and facility policy for one (1) of two(2) patients receiving peritoneal dialysis (Patient #4), the facility failed to maintain and review patient treatment records. Patient #4 had a diagnosis of end stage renal disease, an abdominal peritoneal dialysis catheter, and required daily peritoneal dialysis. a) Review of Patient #4’s chart failed to identify dialysis treatment sheets were reviewed and maintained in the patient’s chart since the initiation of home dialysis treatments on 12/21/23. Interview with Staff Person #3 on 2/28/24 at 8:44 AM identified treatment records for Patient #4 were not collected or reviewed due to modem issues, Patient #4’s failure to bring his/her data card into monthly clinic, and Staff Person #3’s failure to obtain Patient #4’s data card during other clinic visits. Staff Person #3 further indicated it was facility policy to collect and review treatment sheets monthly and the nurse’s responsibility to collect, download and review Patient #4’s treatment sheets. A follow-up interview on 2/28/24 at 10:45 AM identified Staff Person #3 failed to train Patient #4 on maintaining written treatment records and should have. Subsequent to surveyor inquiry, Staff Person #3 provided Patient #4’s downloaded computerized treatment sheets dated 12/21/23 to 2/18/24 on 2/28/24. Review and interview with Staff Person #3 on 2/28/24 at 8:44 AM regarding the downloaded computerized treatment sheets dated 12/21/23 to 2/18/24 failed to identify Patient #4’s weight, vitals, and dialysate solution used for each treatment. Review of the Home Therapies Patient Treatment Record Keeping policy dated 9/5/23 indicated patients would bring portable cycler data devices (USB data cards) and all paper flowsheets to each monthly clinic visit, home treatment records would be reviewed by the home therapy registered nurse during patient monthly clinic visits to identify trends, errors or omissions, and other issues or concerns to be addressed with the proper patient and/or care partner, and that home treatment records would be maintained in the patient’s medical record. Furthermore, the policy directed to train patients and care partners to complete paper treatment flowsheets as a backup documentation method.”