Davita Stamford Dialysis

“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: 47491 Based on observations made during a flash tour of the facility on 8/27/24, the facility failed to provide a sanitary environment to minimize transmission of infectious agents. The findings included: 1. Observations on 8/27/24 from 9:00 AM to 9:10 AM identified the following: a. Several dried, brownish red spots were observed on the patient side of the privacy curtain at Station #3, #8, #9, #12, #13, #14, #15, #16, #17, #18, #19, and #21. Observation and interview with the Charge Nurse on 8/27/24 at 9:15 AM identified the dried, brownish red spots on the curtains on all but Station #14 were dried blood and the spots on Station #14’s curtain was dried iodine. The Charge Nurse further identified the curtains should be cleaned with 1:10 bleach with routine station disinfection following each patient treatment to remove any blood splatter and wasn’t able to explain why this wasn’t done. Interview with the Facility Administrator on 8/27/24 at 9:25 AM identified station curtains should be wiped down at the end of each day and should not be left with dried blood stains/splatter on them. The Facility Administrator further identified the facility was responsible for providing a clean and sanitary treatment station for each patient and staff was responsible for ensuring the station, including the curtains, were clean. Review of the Infection Control for Dialysis Facilities policy directed the cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials. b. An observation made at 9:36 AM identified the Charge Nurse cleaning the back of the dialysis machine and wall box of Station #8 while a patient was receiving his/her dialysis treatment. Interview with the Charge Nurse at 9:43 AM on 8/27/24 identified the reason he/she was cleaning the back of the machine and wall box at Station #8 was because dried blood was seen on the back of the machine and wall box. The Charge Nurse further indicated that the machine and wall box should have been cleaned at the end of the patient’s dialysis treatment when the station was vacated. Review of the Infection Control for Dialysis Facilities policy directs the dialysis station must be completely vacated by the previous patient before teammates could bring disinfection supplies to the station, and clean or disinfect the station.”

“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: 47491 Based on observations, review of clinical records, interview, and policy review the facility failed to ensure gloves were donned appropriately when coming into contact with the hemodialysis machine. The findings included: 1. Observations of the treatment floor made on 9/3/24 included: a. At 11:09 AM, the machine at Station #3 had alarmed. The charge nurse approached Station #3’s machine to address an alarm and covered his/her forefinger with the glove instead of applying the glove properly to cover his/her entire hand. b. At 11:20 AM, Staff Person #1 was observed collecting information from Station #3’s machine and had covered his/her forefinger with the glove instead of applying the glove properly to cover his/her entire hand. Interview with the Charge Nurse on 9/3/24 at 11:56 AM identified gloves should be properly applied (fully covering the hand(s) when adjusting the settings or addressing the alarms of the dialysis machine. Review of the Infection Control policy directs disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station.”

“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: 44675 Based on a review of observation, interview, and policy review, the facility failed to ensure a visitor inside the treatment floor had personal protective equipment provided and worn in accordance with facility policy. The findings include: Observation conducted on 8/27/24 at 10:00 AM identified Staff Person #6 initiating treatment for Patient #29. Patient #29 had a visitor present sitting in a chair across from the patient. Patient #29’s left upper arteriovenous fistula (AVG) was cannulated by Staff Person #6, at which time, Patient #29’s visitor stood next to Patient #29 overlooking the cannulation procedure. Staff failed to provide and ensure Patient #29’s visitor had the required personal protective equipment (PPE). Patient #29’s visitor remained without PPE on the treatment floor until 12:50 PM (approximately 3 hours later). Review of the infection control for dialysis facilities policy directed appropriate PPE 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. Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, physicians and visitors when in the treatment area.”

“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: 44675 Based on observation, clinical record review, interview and review of facility policy, the facility failed to clean and disinfect the hemodialysis station after hemodialysis treatment in accordance with facility policy. The finding included: a. Observation conducted on 8/27/24 at 9:40 AM identified Staff Person #5 cleaning and disinfecting Station #7 after a hemodialysis treatment. Staff Person #5 failed to clean and disinfect the machine drain lines, wall box and back counter. b. Observation conducted on 8/27/24 at 9:48 AM identified Staff Person #4 cleaning and disinfecting Station #31 after a hemodialysis treatment. Staff Person #4 failed to clean and disinfect the machine drain lines, wall box and back counter. c. Observation conducted on 8/27/24 at 10:05 AM identified Staff Person #1 cleaning and disinfecting Station #18 after hemodialysis treatment. Staff Person #1 cleaned the wallbox, discarded the bleach cloth, and with the same set of gloves cleaned Station #18’s hemodialysis chair. Staff Person #1 failed to remove her gloves and perform hand hygiene after coming into contact with the wall box. Review of the infection control for dialysis facilities policy identified surfaces to disinfect include but are not limited to all surfaces in contact with the patient or their belongings and frequently contacted by healthcare personnel.”

“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: 44675 Based on a review of clinical records, interview, and policy review for one (1) peritoneal dialysis patients the facility failed to draw antigen levels on a hepatitis susceptible patient (Patient #3), and for and two (2) hemodialysis patients (Patients #6 and #16) reviewed for hepatitis, the facility failed to offer and administer the hepatitis vaccine for a patient who became susceptible to the hepatitis virus. The findings include the following: 1. Patient #3 had diagnoses that included ESRD. Review of the physician’s order directed peritoneal dialysis daily for eight (8) hours with an abdominal peritoneal dialysis catheter and an estimated dry weight (EDW) of 70 kg. Review of Patient #3’s blood work dated 4/3/24 identified a hepatitis B antibody level of 3 (which indicated the patient was susceptible to the hepatitis B virus). Review of April 2024 bloodwork results and interview with the Staff Person #4 on 9/3/24 at 1:13 PM failed to identify a hepatitis B surface antigen level was drawn. Staff Person #4 further indicated the hepatitis B surface antigen was to be tested monthly until the patient became immune or was non-susceptible. 2. Patient #6 had diagnoses that included ESRD. Review of the physician’s order directed hemodialysis three (3) times weekly for three (3) hours with a left forearm arteriovenous fistula (AVF) and an estimated dry weight (EDW) of 59 kg. Review of Patient #6’s hepatitis B antibodies identified on 9/13/22 Patient #6’s antibodies were 11 (not susceptible for contracting hepatitis B virus). On 3/14/23 Patient #6’s hepatitis B antibodies decreased to 3 (susceptible of contacting hepatitis B virus). On 3/12/24 Patient #6’s hepatitis B antibodies were less than 3. Review of Patient #6’s Energix administration log (hepatitis B vaccination) identified Energix was administered on 3/14/24. The facility failed to administer a booster dose subsequent to Patient #6 becoming susceptible on 3/14/23 (for over a year). 3. Patient #16 had diagnoses that included ESRD. Review of the physician’s order directed hemodialysis three times weekly for three (3) hours with a right central venous catheter (CVC) and an estimated dry weight (EDW) of 69 kg. Review of Patient #16’s hepatitis B antibodies identified on 6/29/23 Patient #16’s antibodies were less than 3 (susceptible of contracting hepatitis B virus). On 8/13/24 Patient #16’s hepatitis B antibodies remained less than 3. Review of Patient #6’s Energix administration log (hepatitis B vaccination) identified Energix was administered on 8/15/24 ( 13 months after the patient was first identified to be susceptible). The facility failed to administer a booster dose subsequent to Patient #16 susceptibility identified on 6/29/23. Interview with the Clinical Services Director on 9/3/24 at 12:30 PM identified Patient #6 should have had a hepatitis B booster administered when his/her antibodies decreased on 6/29/23. Interview with the FA on 9/3/24 at 2:00 PM identified the clinical coordinator is responsible for monitoring patients hepatitis status and vaccinations. She identified there was a change in clinical coordinator last year and the current clinical coordinator is catching up on vaccinations. Review of the hepatitis B policy directed on annual re-testing of immune patients due to vaccination, antibodies of less than 10 with nephrologist order would be administered a booster dose of the vaccine, for monthly antigen testing for patients with an antibody level of less than 10.”

“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 observations made during a flash tour of the facility, the facility failed to dispose of multi-use medication vials by their date of expiration and failed to draw heparin utilizing aseptic technique. The findings included: a. Two opened vials of multi-use Epogen (a medication used to stimulate red blood cell production) were found in the refrigerator of the med room, one with an opened date of 5/18/24 and one without an opened date. Interview with the Charge Nurse on 8/27/24 at 10:15 AM identified opened vials of medication should be discarded within 28 days of being opened. Review of the Medication policy directed to date multi-use vials when opened and to discard within 28 days unless the manufacturer specifies a different date for the vial. b. Staff Person #2 was observed drawing heparin without first wiping the stopper of the vial with an alcohol prep pad. Interview with Staff Person #2 on 9/3/24 at 2:44 PM identified he/she wasn’t aware he/she did not disinfect the top of the heparin vial prior to drawing heparin or that he/she needed to disinfect the stopper of the heparin vial with an alcohol prep pad each time heparin was drawn. Review of the Medication policy directed aseptic technique must be used for disinfection of the stopper prior to any entry of the vial.”

“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: 32738 Based on observation during tour on 8/27/24 while accompanied by the Regional, Bio-Medical Technician the facility failed to maintain a safe environment. The findings include the following: 1. On 08/27/24 at 12:45 PM, the surveyor while accompanied by the Bio Med Technicians and the Area Biomed Supervisor (ABS) observed that the flooring in the dialysis treatment room was worn and not a cleanable surface. 2. On 08/27/24 at 12:30 PM, the surveyor while accompanied by the Bio Med Technicians and the Area Biomed Supervisor (ABS) observed that sinks and countertops were worn and not a cleanable surface. 3. On 08/27/24 at 1:15 PM the surveyor while accompanied by the Director of Maintenance and a facility representative, observed that the door to the storge area did not close and latch as required by section # 7.2.1.7 of the “Life Safety Code”

“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: 32738 Based on observation during tour on 8/27/24 while accompanied by the Regional, Bio-Medical Technician the facility failed to maintain a safe environment. The findings include the following: On 08/27/24 at 12:50 PM, the surveyor while accompanied by the Bio Med Technicians and the Area Biomed Supervisor (ABS) observed that the door frame for the emergency exit was rusted and rotted.”

“PE-LSC-SPRINKLERS CFR(s): 494.60(e)(2) (2) Notwithstanding paragraph (d)(1) of this section, dialysis facilities participating in Medicare as of October 14, 2008 that require sprinkler systems are those housed in multi-story buildings construction Types II(000), III(200), or V(000), as defined in the Life Safety Code, section 21.1.6.1, which were constructed after January 1, 2008, and those housed in high rise buildings over 75 feet in height, which were constructed after January 1, 2008. This Standard is not met as evidenced by: 32738 Based on observation during tour on 8/27/24 while accompanied by the Regional, Bio-Medical Technician the facility failed to maintain a safe environment. The findings include the following: On 08/27/24 during document review the surveyor was not provided with documentation from the Bio Med Techs or the facility to indicate that the FDC for the wet-pipe sprinkler system is being maintained, as required by section # 13.7 of NFPA 25, “Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems” and as part of the facilities’ preventative maintenance program; i.e. facility did not have paperwork to show the FDC was tested.”

“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: 44675 Based on a review of clinical records, interview, and policy review for one (1) of two (2) hemodialysis patients reviewed for cardiac arrest (Patients #6), the facility failed to address an abnormal finding with the licensed nurse. The findings include the following: Patient #6 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s order directed hemodialysis three (3) times weekly for three (3) hours with a left forearm arteriovenous fistula (AVF) and an estimated dry weight (EDW) of 59 kg. Review of Patient #6’s treatment flowsheet dated 1/13/24 identified treatment was initiated by a Patient Care Technician (PCT) at 10:01 AM and Patient #6’s pulse was 58 BPM (normal range 60-100 BPM). The flowsheet failed to identify if the licensed nurse was notified of Patient #6’s abnormal pulse. At 10:32 AM the check was completed by a PCT and Patient #6’s pulse was 53 BPM. The flowsheet failed to identify if the licensed nurse was notified of Patient #6’s abnormal pulse. At 11:02 AM Patient #6’s blood pressure dropped, the patient was not responding and the nurse was called to the scene and CPR was initiated. Interview with the Clinical Services Director on 9/3/24 at 12:30 PM identified for a heart rate less than 60 BPM, the licensed nurse should be notified per facility policy. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed that abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “abnormal findings” section in this policy). The policy directed an abnormal blood pressure finding would be a systolic less than 90 mm/HG and a pulse less than 60. It further directed if a patient is not able to stand, document the reason and sitting BP.”

“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: 47491 Based on a review of clinical records, interview, and policy review for four (4) out of eleven (11) hemodialysis patients reviewed for prescription adherence (Patient #7, #14, #17, and #19), the facility failed to ensure the patient’s hemodialysis treatment was administered in accordance with the physician orders. The findings include the following: 1. Patient #7 had diagnoses which included end stage renal disease, a physician’s order for hemodialysis treatment three (3) times weekly utilizing a central venous catheter in the right chest for three (3) hours and thirty (30) minutes, a 3.0 potassium/2.5 calcium dialysate bath, blood flow rate (BFR) of 400, and dialysate flow rate (DFR) of 500. A review of Patient #7’s treatment flowsheets identified the following: a. On 12/12/23, treatment was initiated at the prescribed blood flow rate (BFR) of 400, however was decreased to 350, then to 300 without documenting the reason for the reduced BFR. 2. Patient #14 had diagnoses which included end stage renal disease, a physician’s order for hemodialysis treatment three (3) times weekly utilizing a central venous catheter in the right chest for three (3) hours and thirty (30) minutes, a 3.0 potassium/2.5 calcium dialysate bath, blood flow rate (BFR) of 400, and dialysate flow rate (DFR) of 500. A review of Patient #14’s treatment flowsheets identified the following: a. On 8/1/24, treatment was initiated at the prescribed BFR of 400, however was decreased to 250, then increased to 350 without documenting the reason for the reduced BFR. b. On 8/10/24, treatment was initiated at the prescribed BFR of 400, however was decreased to 250 , then to 200 without documenting the reason for the reduced BFR. On 8/15/24, Patient #10’s physician’s order changed to use of a left upper arm arteriovenous fistula for treatment for three (3) hours and thirty (30) minutes, a 3.0 potassium/2.5 calcium dialysate bath, blood flow rate (BFR) of 400, and dialysate flow rate (DFR) of 500. c. On 8/15/24, treatment was initiated at the prescribed BFR of 400, however was decreased to 250, then to 200 without documenting the reason for the reduced BFR. 3. Patient #17 had diagnoses that included end stage renal disease. A physician’s order for hemodialysis treatment three (3) times weekly for three (3) hours and thirty (30) minutes utilizing an arteriovenous fistula in the upper left arm, a 3.0 potassium/2.5 calcium dialysate bath, blood flow rate (BFR) of 450, and dialysate flow rate (DFR) of 800. A review of Patient #17’s treatment flowsheets identified the following: a. On 8/13/24, treatment was initiated at the prescribed BFR of 450, however was decreased to 400 without documenting the reason for the reduced BFR. b. On 8/20/24, treatment was initiated at a BFR of 350, then increased to 400 and maintained at 400 for the remainder of the treatment without documenting the reason for the reduced BFR. Treatment on 8/20/24 was also initiated at a dialysate flow rate of 500 without documenting the reason for the reduced DFR. 4. Patient # 19 was admitted to the facility with diagnoses that included end stage renal disease. Patient #19’s physician orders included hemodialysis treatment three times a week for three (3) hours and thirty (30) minutes utilizing a central venous catheter, 3.0 potassium/2.5 calcium dialysate bath, blood flow rate (BFR) of 400, and dialysate flow rate (DFR) of 500. A review of Patient #19’s treatment flowsheets identified the following: a. On 8/9/24, treatment was initiated at the correct BFR of 400, however was decreased to 350 without documenting the reason for the reduced BFR. On 8/26/24, Patient #19’s physician’s order changed to use of a left upper arm arteriovenous fistula, 3.0 potassium/2.5 calcium dialysate bath, blood flow rate (BFR) of 400, and a dialysate flow rate (DFR) of 500. b. On 8/26/24, treatment was initiated at a BFR of 300 and maintained at 300 for the entire treatment without documenting the reason for the reduced BFR. Treatment on 8/26/24 was also initiated at a DFR of 800 and maintained at 800 for the entire treatment without documenting the reason for the increased DFR. c. On 8/28/24, treatment was initiated at a BFR of 350 and maintained at 350 for the entire treatment without documenting the reason for the reduced BFR. Interview with the manager of clinical services on 9/3/24 at 2:31 PM identified facility practice was to run patient’s treatments at the prescribed BFR/DFR and if staff were unable to achieve the prescribed BFR/DFR, they were to document it in the e-line (vitals comment section of the electronic medical record). The Manager of Clinical Services further indicated if the issues persisted, the physician should be contacted and informed of the issue.”

“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 a review of clinical records, interview, and policy review for three (3) of twenty one (21) hemodialysis patients review for fluid balance (Patient #9, #10, and #19), the facility failed to address the patient not meeting the prescribed target weight in the medical record, for one (1) of two (2) residents reviewed for cardiac arrest (Patient #7), the facility failed to notify the physician of abnormal post treatment blood pressures, and for seven (7) of twenty- one (21) hemodialysis patients reviewed for blood pressures (Patients #7, #11, #12, #13, #17, #20, and #21), the facility failed to ensure an patient who was ambulatory had a standing blood pressure and pulse pre and post hemodialysis treatment per facility policy. The findings include the following: 1)Patient #9 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours with a right upper arteriovenous fistula (AVF) and an estimated dry weight (EDW) of 45.0 kilograms (kg). The annual stable care plan dated 9/19/23 identified Patient #9’s blood pressure and fluid management goal was to maintain post weight compared to target weight. Review of Patient #9’s hemodialysis treatment sheets identified the following: a) On 8/14/24 Patient #9’s post weight was 48.1 kg (3.1 kg above prescribed EDW). Review of the nursing notes failed to identify Patient #9’s EDW not being achieved, interventions and education provided (if any), and if the physician was notified. b) On 8/16/24 Patient #9’s post weight was 47.6 kg (2.6 kg above prescribed EDW). Review of the nursing notes failed to identify Patient #9’s EDW not being achieved, interventions and education provided (if any), and if the physician was notified. c) On 8/19/24 Patient #9’s post weight was 46.4 kg (1.4 kg above prescribed EDW). Review of the nursing notes failed to identify Patient #9’s EDW not being achieved, interventions and education provided (if any), and if the physician was notified. d) On 8/21/24 Patient #9’s post weight was 48.1 kg (3.1 kg above prescribed EDW). Review of the nursing notes failed to identify Patient #9’s EDW not being achieved, interventions and education provided (if any), and if the physician was notified. e) On 8/23/24 Patient #9’s post weight was 46.5 kg (1.5 kg above prescribed EDW). Review of the nursing notes failed to identify Patient #9’s EDW not being achieved, interventions and education provided (if any), and if the physician was notified. f) On 8/26/24 Patient #9’s post weight was 48.5 kg (3.5 kg above prescribed EDW). Review of the nursing notes failed to identify Patient #9’s EDW not being achieved, interventions and education provided (if any), and if the physician was notified. 2) Patient #10 was admitted to the facility with diagnoses that included end stage renal disease. Review of physician’s orders directed hemodialysis three (3) times weekly for four(4) hours with a left forearm arteriovenous graft, and an estimated dry weight of 117.5 kg. Review of Patient #10’s hemodialysis treatment sheets identified the following: a. On 7/29/24, Patient #10’s post weight was 123.7 kg (6.2 kg above the prescribed EDW). The physician identified the need for extra treatments to come closer to EDW, however no additional treatments were offered or scheduled. b. On 7/31/24, Patient #10’s post weight was 122.0 kg (4.5 kg above the prescribed EDW). Review of nursing notes failed to identify Patient #10’s EDW was not achieved, if the physician was notified, or if additional treatments were offered or scheduled. c. On 8/2/24, Patient #10’s post weight was 121.2 kg (3.7 kg above the prescribed EDW). Review of nursing notes failed to identify Patient #10’s EDW was not achieved, if the physician was notified, or if additional treatments were offered or scheduled. 3) Patient #19 had diagnoses that included end stage renal disease. Review of physician’s orders directed to hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes with a left upper arm arteriovenous fistula, and an estimated dry weight of 83.0 kg. Review of Patient #19’s hemodialysis treatment sheets identified the following: a. On 8/5/24, Patient #19’s post weight was 86.8 kg (3.8 kg above the prescribed EDW). Review of nursing notes failed to identify Patient #10’s EDW was not achieved and if the physician was notified. b. On 8/7/24, Patient #19’s post weight was 89.2 kg (6.2 kg above the prescribed EDW). Review of nursing notes failed to identify Patient #10’s EDW was not achieved and if the physician was notified. c. On 8/9/24, Patient #19’s post weight was 88.4 kg (5.4 kg above the prescribed EDW). Review of nursing notes failed to identify Patient #10’s EDW was not achieved and if the physician was notified. Interview with the Director of Clinical Services on 9/3/24 at 2:33 PM identified if a patient is not achieving their prescribed target weight, the physician should be notified for an evaluation of the patient. She further identified the patient should be offered a extra treatment. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed if an abnormal finding or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will use their clinical judgement based on individual patient needs to determine if any clinical interventions or notification of the physician is necessary. Abnormal findings for fluid status post treatment is if a patient is above 1 kg from the target weight. 4) Patient #7 had diagnoses which included end stage renal disease, a physician’s orders for hemodialysis treatment three (3) times weekly utilizing a central venous catheter in the right chest Review of the following treatment details report identified the following: a. A hemodialysis treatment dated 12/1/23 identified a pre-treatment sitting blood pressure of 210/108 and heart rate of 108, and a post treatment sitting blood pressure of 188/98 and heart rate of 106. No blood pressure parameters were identified, and the physician was not notified of the abnormal findings. b. A hemodialysis treatment dated 12/4/23 identified a pre-treatment sitting blood pressure of 244/124, pre-treatment standing blood pressure of 243/148, and a post-treatment sitting blood pressure of 248/125. No blood pressure parameters were identified, and the physician was not notified of the abnormal findings. c. A hemodialysis treatment dated 12/7/23 identified elevated blood pressures of 192/107, 209/98, 218/94, 214/95, 209/102, and 215/103 without documenting the registered nurse was notified. d. A hemodialysis treatment dated 12/9/24 identified elevated blood pressures of 215/135, 222/112, 192/108, 219/113, 232/116, and 213/109 without documenting the registered nurse was notified. Interview with the Manager of Clinical Services on 9/3/24 at 2:00 PM identified pre and post treatment systolic blood pressures that exceed 180 and pre and post treatment diastolic blood pressures that exceed 100 require physician notification. Review of the Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment policy defines abnormal blood pressures as greater than 180 systolic and greater than 100 diastolic pre-treatment, and greater than 140 systolic and greater than 90 diastolic post-treatment. The policy further indicates the licensed nurse is to notify the physician as needed of changes in patient status. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is a concern for the patient’s condition or potential safety of initiating dialysis. 5. Review of Patient #7’s hemodialysis flowsheets dated 12/7/23 and 12/9/23 identified Patient #7 ambulated independently, failed to identify a pre and post treatment standing blood pressure, and reason why a pre and post standing blood pressure were not obtained. 6. Patient #11 had diagnoses that included end stage renal disease. Patient #11’s physician’s orders included hemodialysis treatment three (3) times a week for three (3) hours and thirty minutes, 2 K 2.0 Ca dialysate and an estimated dry weight (EDW) of 84.5 kg. Review of Patient #11’s hemodialysis flowsheets identified on 8/2/24, 8/5/24, 8/14/24, 8/16/24, 8/19/24, 8/21/24, 8/23/24 and 8/26/24 Patient #11 ambulated independently and did not have a pre and post treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. 7. Patient #12 had diagnoses that included end stage renal disease. Patient #12’s physician’s orders included hemodialysis treatment three times a week for three (3) hours and forty-five minutes (45), 2K 2.5Ca dialysate and an EDW of 90.0 kg. Review of Patient #12’s hemodialysis flowsheets identified on 8/5/24, 8/7/24, 8/12/24, 8/14/24, 8/16/24, 8/19/24, and 8/21/24 Patient #12 ambulated with a walker and did not have a post-treatment standing blood pressure and/or the reason why a post-treatment standing blood pressure was not obtained. Review of hemodialysis flowsheets identified on 8/23/24 and 8/26/24 Patient #12 ambulated independently and did not have a post-treatment standing blood pressure and/or the reason why a post-treatment standing blood pressure was not obtained. 8. Patient #13 had diagnoses that included end stage renal disease. Patient #13’s physician’s orders included hemodialysis treatment three times a week for three hours, 2 K 2.5 Ca dialysate and EDW of 62.5 kg. Review of Patient #13’s hemodialysis flowsheets identified on 8/8/24 and 8/10/24 Patient #13 ambulated with a walker and did not have a post standing blood pressure and/or the reason why a standing blood pressure was not obtained/documented. Review of the flowsheet dated 8/13/24 identified Patient #13 ambulated with a walker and did not have a pre and post standing blood pressure and/or the reason why a standing blood pressure was not obtained/ documented. Review of the flowsheets dated 8/15/24, 8/17/24 and 8/20/24 identified Patient #13 ambulated with a walker and did not have a pre standing blood pressure and/or the reason why a standing blood pressure was not obtained/documented. 9. Patient #17 had diagnoses that included end stage renal disease. Patient #17’s physician’s orders included hemodialysis treatment three (3) times a week for three (3) hours and thirty minutes (30), 3 K 2.5 Ca dialysate, and an EDW of 117.0 kg. Review of Patient #17’s hemodialysis flowsheet identified on 8/10/24, 8/15/24, 8/24/24, 8/27/24, 8/29/24, and 8/31/24 Patient #17 ambulated independently and did not have a post-treatment standing blood pressure and/or the reason why a post-treatment standing blood pressure was not obtained. 10. Patient #20 had diagnoses that included end stage renal disease. Patient #20’s physician’s orders included hemodialysis treatment three (3)times a week for three (3) hours, 2 K 3 Ca dialysate and EDW of 48 kg. Review of Patient #20’s hemodialysis flowsheets identified on 8/2/24, 8/5/24, 8/7/24, 8/9/24, 8/14/24, 8/16/24, 8/21/24, 8/23/24 and 8/26/24 Patient #20 ambulated independently and did not have a pre and post treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. 11. Patient #21 had diagnoses that included end stage renal disease. Patient #21’s physician’sorders included hemodialysis three times a week for three hours and forty-five minutes, 2 K 2.5 Ca, and an EDW of 93.0 kg. Review of Patient #21’s hemodialysis flowsheets identified on 8/17/24, 8/20/24, 8/22/24, 8/24/24, 8/27/24, and 8/27/24 Patient #21 ambulated independently and did not have a post-treatment standing blood pressure and/or the reason why a post-treatment standing blood pressure was not obtained. Interview with the Director of Clinical Services on 9/3/24 at 2:33 PM identified if a patient is ambulatory, the expectation is for that patient to have a standing pre and post treatment blood pressure. If the patient refuses to take a standing blood pressure, it should be documented in the medical record. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed that for blood pressures post treatment, if the patient is not able to stand, to document the reason.”

“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 a review of clinical records, interview, and policy review for two (2) of ten (10) hemodialysis patients reviewed for anemia (Patients #13 and #15), the facility failed to address a decrease in hemoglobin and obtain a hemoglobin level post hospitalization in accordance with facility policy. The findings include the following: 1. Patient #13 had diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours with a right central venous catheter (CVC) and an estimated dry weight (EDW) of 62.5 kg. A physician’s order dated 5/17/24 through 6/20/24 directed 50 mcg Mircera (a medication that supports red blood cell production) every two (2) weeks (per protocol). Review of Patient #13’s bloodwork identified on 5/14/24 Patient #13’s hemoglobin was 7.4 (expected lab range 10-12). A physician’s order dated 5/20/24 through 6/3/24 directed 75 mcg Mircera every two (2) weeks. Review of Patient #13’s bloodwork identified on 5/28/24 Patient #13’s hemoglobin was 6.7. An anemia manager note dated 5/31/24 identified Patient #13’s current Mircera dose was 75 mcg every two (2) weeks per the physician on 5/20/24. The note further identified she asked the clinic to assess and review with the provider as appropriate. A physician’s order dated 6/3/24 through 6/26/24 directed 150 mcg Mircera every two weeks. MD progress note dated 6/6/24 identified Patient #13 received a blood transfusion of packed red blood cells on 6/6/24. Review of the medical record failed to identify any progress notes identifying if Patient #13’s hemoglobin result of 6.7 on 5/28/24 was addressed prior to Patient #13 receiving a blood transfusion on 6/6/24 (9 days after the bloodwork). Interview with the Clinical Services Director on 9/3/24 at 2:31 PM identified she would expect an intervention documented and an outcome for a hemoglobin of 6.7. 2. Patient #15 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours with a left forearm arteriovenous fistula (AVF) and an estimated dry weight (EDW) of 71.5 kg. A physician order dated 5/25/24 through 7/12/24 directed 150 mcg Mircera every two weeks. Review of Patient #15’s bloodwork identified on 5/28/24 Patient #15’s hemoglobin was 7.6 (expected lab range 10-12). Review of Patient #15’s medical record identified Patient #15 was hospitalized from 6/11/24 through 7/2/24 due to a gastrointestinal bleed. Patient #15 received hemodialysis treatment in the facility on 7/4/24 but the facility failed to draw a hemoglobin lab on Patient #15’s first treatment back in the facility. Review of Patient #15’s labs identified on 7/9/24 Patient #15’s hemoglobin was 7.6. Review of the Mircera protocol directed a one time hemoglobin will be drawn post hospitalization.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 47491 Based on clinical record review, facility documentation, policy review, and interview, for three (3) of three (3) patients reviewed for peritoneal dialysis, (Patient #2, #3, and #8), the facility failed to ensure that peritoneal dialysis treatment sheets were monitored to ensure the dialysate orders were followed in accordance with physician’s orders. 1)Patient #2 had end stage renal disease, required daily peritoneal dialysis treatments, and had a peritoneal dialysis catheter in his/her lower abdomen. 2) Patient #3 had end stage renal disease, required daily peritoneal dialysis treatments, and had a peritoneal dialysis catheter in his/her lower abdomen. 3) Patient #8 had end stage renal disease, required daily peritoneal dialysis treatments, and had a peritoneal dialysis catheter in his/her lower abdomen. Review of Patient #2, Patient #3 and Patient #8’s daily treatment records identified patients were compliant with their daily treatments, however failed to identify Patient #2, Patient #3, and Patient #8 had followed their prescriptions(which specified the concentration of dialysate solution to use with treatments based on weight and/or blood pressure). #Interview with Staff Person #3 on 9/3/24 at 12:22 PM identified patients were expected to follow fluid guidelines when performing home dialysis treatments. Staff Person #3 indicated patients were not entering the specific dialysate concentrations used with each treatment and that he/she took the patient’s verbal confirmation they were following the physician’s prescription. Staff Person #3 further indicated that all thirty-seven of the facility’s peritoneal dialysis patients did not document the specific dialysate solutions used with each treatment. Review of the Home Dialysis Monitoring and Ongoing Patient Education directs the facility to document in the patient’s medical record that the patient, the caregiver, or both have received and demonstrated an adequate comprehension of the training by reviewing home patient clinical records for evidence of compliance with their training.”

“PQ-STAFF NURSE-MEET STATE REQUIREMENTS CFR(s): 494.140(b)(4) Each nurse who provides care and treatment to patients must be either a registered nurse or a practical nurse who meets the practice requirements in the State in which he or she is employed. This Standard is not met as evidenced by: 32738 Based on review of facility schedules and interviews, the facility failed to ensure that the clinic was staffed in accordance with the requirements of the state agency. Review of the staffing schedules from 8/14-9/3/24 identified the following: a) On 8/14/24 Pod one (1) had twelve (12) patients and was staffed with one (1) Registered Nurse (RN) and three (3) Patient Care Technicians (PCT’s). b) On 8/16/24 Pod one (1) had twelve (12) patients and was staffed with one RN and two (2) Certified Clinical Hemodialysis Technician (CCHT) and one PCT. c) On 8/22/24 Pod 1 had twelve (12) patients and was staffed with one RN and 2 CCHT’s and one (1) PCT. Interview with the Director of Clinical services (DCS) on 9/3/24 at 11:30 AM identified that there should be two (2) licensed staff and two (2) un-licensed staff in a pod of twelve making the staffing of licensed and unlicensed equal. Review of the state public health code identified that a PCT shall compromise not more than fifty (50) % of staff providing direct care on the dialysis unit and at least fifty (50%) will be licensed nurses.”

“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: 32738 Based on review of clinical records, observations, interviews, and review of facility policy for one (1) of nine (9) patients reviewed for vascular access visibility, the facility failed to ensure a patient’s vascular access remained visible during hemodialysis treatment, and for (1) of three (3) patients (Patient #8) reviewed for tuberculosis testing, the facility failed to complete appropriate tuberculosis testing per facility policy, and for four (4) of seven (7) patients (Patient #22, 23, 24, and 27) reviewed for grievances, the facility failed to ensure that grievances were addressed in entirety and that any education, follow-up was documented, The findings included: 1. Patient # 22 had diagnoses that included end stage renal disease, an arteriovenous fistula access in his/her right forearm, a physician’s order for hemodialysis three times weekly for three (3) hours and thirty (30) minutes per treatment, utilizing fifteen (15) gauge needles, a 3.0 potassium/ 2.5 calcium dialysate bath, at a blood flow rate of 450, and dialysate flow rate of 500. Observation of Patient #22 while receiving treatment on 9/3/24 identified the following: a. At 11:00 AM, surveyor identified Patient #22’s right forearm access was covered by a blanket. b. At 11:09 AM, surveyor identified Patient #22’s machine alarmed and stopped. The charge nurse came to the patient’s station and reset the patient’s machine, however, failed to check his/her access and adjust the blanket to allow visualization of the access site. c. At 11:12 AM, Staff Person #1 entered Patient #22’s station to review vitals for the patients they were assigned. The computer used to review the patient’s vitals was four (4) to five (5) feet away from Patient #22. d. At 11:19 AM, Staff Person #1 wrote on a sheet of paper on top of Patient #22’s dialysis machine. Patient #22’s access remained covered. e. At 11:20 AM, Staff Person #1 checked data on Patient #22’s dialysis machine, reset the screen, and failed to check and uncover his/her access site. f. At 11:21 AM, Staff Person #1 stepped away from Patient #22’s machine without checking his/her access and/or uncover the access site. Interview with Staff Person #1 on 9/3/24 at 11:23 AM identified Resident #22’s access site was still covered as Staff Person #1 had to uncover the site to show the surveyor where the vascular access was located. Staff Person #1 identified that the patient’s access site should be visible at all times during hemodialysis treatment. Staff Person #1 identified he/she did not check Patient #22’s access while standing at the computer next to the patient’s station, checking the screen on his/her dialysis machine, or reviewing his/her vitals and dialysis data. Interview with the Medical Director on 9/4/24 at 2:45 PM identified a hemodialysis access should be visible throughout a patient’s treatment and that it was unacceptable, although it does happen at times, for a patient’s access to be covered for twenty-three minutes during treatment. The Medical Director further indicated staff should check the patient’s access each time they are addressing machine alarms or reviewing vitals during their thirty-minute checks and that the dangers of having a covered access during treatment include dislodgement of the needle, which could result in a catastrophic event as a patient could lose an excessive amount of blood without detection. Review of the Intradialytic Data Collection/Assessment policy directs the vascular access site, blood line connections, and the patient’s face should be visible throughout the dialysis treatment. 2. Patient #8 was admitted to the facility on 8/6/24, had diagnoses that included end stage renal disease, a physician’s order for daily peritoneal dialysis treatments, and had an abdominal peritoneal dialysis catheter. Review of Patient #8’s Vaccination Surveillance Report identified the patient was screened for tuberculosis following admission to the facility on 8/7/24, however failed to indicate he/she was screened for tuberculosis a second time. Interview with Staff Person #4 on 9/3/24 at 1:13 PM identified the second tuberculosis screen is to be performed one (1) to three (3) weeks after the initial tuberculosis screening was administered, which would have been no later than 8/28/24. Review of the Tuberculosis Infection Control policy directed to administer two TST’s upon admission to the facility, the first as soon as possible and the second one to three weeks after the first. 3. a. Review of a grievance form dated 7/1/24 identified that the Patient #24 feels like h/she is mistreated and treated unfairly by the team within the clinic. The resolution identified that the FA re-educated on how they are treating the patients, however, the facility did not have any documentation regarding the education. b. Review of a grievance form dated 6/28/24 identified that Patient #22 had complained about staff member #1’s behavior, the staff member was loud, disorganized, disrespectful and ignoring alarms. The Facility Administrator addressed the concerns with the patient on 6/28/24, the patient reiterated that she did that h/she did not was staff member #1 taking care of h/her anymore. The resolution identified that the FA listened to the patient’s concerns and assured h/her that Staff member #1 will not take care of h/her anymore. The FA would continue to follow up with the patient. The grievance failed to identify that an investigation was conducted or that provided education and or in-serving regarding the patient’s concerns that the staff member was being disrespectful and ignoring machine alarms. c. Review of a grievance dated 6/28/24 identified that on 6/24/24 Patient #23 identified that he/she asked Staff Person #1 to put the hemodialysis needle in a different spot, because h/she’s access was sore. Staff member #1 “snapped” at Patient #23 stating “I don’t need you to tell me where to put it, I know what I’m doing.” Patient #23 identified that Staff Person #1 was rude and disrespectful the duration of h/her treatment and did not answer machine alarms. The FA spoke with Patient #23 and ensured that Staff member #1 will not care for h/her. The grievance failed to identify that an investigation was conducted regarding the patient concerns or that the facility educated/in-serviced Staff member #1 the in regards to concerns of Patient #23 about being treated in a disrespectful manner and failure to answer alarms. d. Review of a grievance dated 5/30/24 identified that Patient #27 that a teammate from another clinic was working with h/her and was very rude and did not escort her after treatment as h/she was a fall risk and needed assistance. The daughter claimed it was “elder abuse”. The interview an investigation portion of the form identified that the FA spoke with the patient and was assured that the teammate would no longer take care of h/her because he does not work at the clinic. The grievance failed to identify that an investigation was conducted in regard to the patient’s concern. Review of the grievance policy identified that the FA will discuss the grievance with the patient, investigate, and take appropriate action towards a solution.”