Davita Bloomfield Dialysis

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 47491 Based on review of clinical records, observations, interview, and review of facility documentation for two (2) of five (5) patients reviewed for hand hygiene, the facility failed to offer hand hygiene to patients after holding their access sites following treatment. The findings included: 1. Patient #11 had diagnoses which included end stage renal disease. Physician’s orders directed to in-center hemodialysis treatments three times weekly for three (3) hours and (30) minutes, with a 2.0 potassium/2.5 calcium bath, run at a blood flow rate of 450 milliliters per minute, a dialysate flow rate of 600 milliliters per minute, using an upper right arteriovenous fistula. Observation made on 1/22/25 at 2:30 PM identified Patient #11 holding his/her access sites following treatment with his/her gloved left hand. At 2:56 PM, Patient #11 had removed his glove, did not perform hand hygiene, opened the clinic door with his left hand to exit the clinic and obtain his weight, re-entered the clinic to get his/her coat and rested his/her hand on the back counter while speaking with staff, and exited the clinic again without performing hand hygiene. 2. Patient #12 had diagnoses which included end stage renal disease. Physician’s orders directed in-center hemodialysis treatments three (3) times weekly for three (3) hours and (30) minutes, with a 2.0 potassium/2.5 calcium bath, run at a blood flow rate of 450 milliliters per minute, a dialysate flow rate of 600 milliliters per minute, using an upper left arteriovenous fistula. Observation made on 1/22/25 at 2:40 PM identified Patient #12 holding his/her access sites following treatment with his/her gloved right hand. Patient #12 had removed his/her glove at 2:48 PM and failed to perform hand hygiene prior to exiting the clinic. Interview with the Group Facility Administrator on 1/22/25 at 4:05 PM identified patients should be performing hand hygiene following glove removal when holding their access sites following treatment. Review of the Infection Control for Dialysis Facilities policy directed patients and caregivers would be encouraged to wash their hands after treatment, before leaving 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: 47491 Based on observations made during station disinfection, the facility failed to properly disinfect a treatment station in between patient treatments. The findings included: 1. Observation of Station #8 disinfection on 1/22/25 at 9:31 AM identified Staff Person #1 failed to clean the primer bucket and had cleaned the back counter with the same cleaning rag previously used to clean the wall box. 2. Observation of Station #13 disinfection on 1/22/25 at 2:50 PM identified Staff Person #2 cleaning up a blood spill on the platform of the dialysis machine and the floor in front of the dialysis machine. Staff Person #2 initially cleaned both areas with a bleach rag. The surveyor was unable to identify the strength of the bleach solution used, however, when cleaning the machine and floor a second time, Staff Person #2 used a 1:100 bleach towel for each. Staff Person #2 did moisten another towel with 1:10 bleach solution to clean the blood spill on the floor, however he/she placed it over the 1:100 bleach towel that was already on the floor and wiped the entire area with the 1:10 bleach rag atop the 1:100 bleach rag. Furthermore, Staff Person #2 failed to clean the area with another towel soaked with 1:10 bleach solution after the blood spill was cleaned up. Staff Person #2 also used 1:100 bleach solution twice when cleaning the platform of the dialysis machine. Staff Person #2 failed to clean the Hansen tubing and back counter when performing station disinfection. Interview with the Manager of Clinical Services on 1/22/25 at 4:06 PM identified blood spills are to be cleaned twice using a 1:10 bleach solution. Review of the Infection Control for Dialysis Facilities policy directed, prior to routine disinfection, staff is to remove all visible blood using 1:10 bleach solution and after all visible blood has been cleaned, teammates are to use a new disposable towel soaked in 1:10 bleach solution and clean the area a second time. The policy further directed the dialysis station would be cleaned and disinfected at the end of each treatment, including the front and sides of the dialysis machine, priming containers, wall box, drain, and supply lines.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for two (2) of three (3) hemodialysis patients reviewed for hepatitis (Patient #3 and #14), the facility failed to ensure a hepatitis B antigen was drawn monthly for a susceptible patient, ensure a hepatitis B panel was drawn on admission for a new patient, and offer the vaccine when the patient was identified as susceptible in accordance with facility policy. The findings include the following: 1. Patient #3 had diagnoses that included end stage renal disease (ESRD). Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours with a left arteriovenous fistula (AVF). Review of Patient #3’s hepatitis labs dated 10/22/24 identified Patient #3’s surface antibodies were less than three (3) (indicating that the patient was susceptible to hepatitis B) and the antigen was negative (not infected with hepatitis B virus). A nursing note dated 10/22/24 identified Patient #3 fell at home and was discharged from the hospital to the skilled nursing facility with a dialysis den for rehabilitation and dialysis treatment.. Review of Patient #3’s medical record identified there were no hepatitis labs (including no monthly antigen) drawn in November 2024. Interview with the Manger of Clinical Services on 1/22/25 at 3:00 PM identified a hepatitis panel should be drawn on admission to the facility. She identified the dialysis den should have drawn a hepatitis B antigen when Patient #3 was treating there in November 2024. Interview with the Manger of Clinical Services for the dialysis den on 1/24/25 at 2:22 PM identified the facility should be drawing hepatitis B antigen’s monthly for patient’s who are susceptible to the virus. Review of the hepatitis B surveillance, vaccination infection control measures and isolation guidance policy directed for an antibody less than ten (10), the patient is susceptible and to test the Hepatitis B antigen monthly. 2. Patient #14 was admitted to the clinic on 10/29/24 with diagnoses that included Acute Kidney Injury (AKI). Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes with a right Central Venous Catheter (CVC). Review of Patient #14’s hepatitis B report dated 10/24/24 (pre-admission report) identified Patient #14’s surface antibodies were less than three (3) (susceptible to hepatitis B), core antibodies were negative (not exposed to hepatitis B virus) and antigen was negative (not infected with hepatitis B virus). Review of Patient #14’s hepatitis labs dated 11/21/24 (29 days after admission dialysis treatment) identified Patient #14’s surface antibodies were five (5) (susceptible to hepatitis B), core antibodies were negative (not exposed to hepatitis B virus) and the antigen was negative (not infected with hepatitis B virus). The medical record failed to identify a hepatitis panel was administered on admission and results known within seven (7) days per facility policy. Review of Patient #14’s consent for hepatitis B vaccine dated 1/21/25 identified Patient #14 received a copy of the vaccine information statement (VIS) and received the first dose (of four) energix vaccines ( Hepatitis B vaccine) on 1/21/25. The medical record failed to identify if the VIS education was discussed prior to 1/21/25 and if the vaccination was offered prior to 1/21/25 (approximately three months after initial treatment start date). Interview with the Manger of Clinical Services on 1/22/25 at 3:00 PM identified a hepatitis panel should be drawn on admission to the facility. Review of the hepatitis B surveillance, vaccination infection control measures and isolation guidance policy directed that all permanent patients including AKI patients will have HBV serological testing drawn immediately upon admission to the facility and results known with seven (7) days of admission (hepatitis B surface Ag, hepatitis B core antibody, and hepatitis B surface antibody). It directed to review the results and determine status and next steps. It identified for an antibody less than ten (10), the patient is susceptible and the offer the vaccination series.”

“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 review of clinical records, observations, interview, and review of facility documentation for two (2) of two (2) patients reviewed for central venous catheters, the facility failed to ensure staff and patient masks were donned properly for infection control purposes. The findings included: 1. Patient #9 had diagnoses that included end stage renal disease. Physician’s orders directed to in-center hemodialysis three times weekly for three (3) hours per treatment with a 2.0 potassium/2.5 calcium bath, 400 milliliter blood flow rate (BFR), 500 milliliter dialysate flow rate (DFR), utilizing a central venous catheter (CVC). Observation made on 1/22/25 at 2:25 PM identified Patient #9 had completed his/her dialysis treatment and was being disconnected from the dialysis machine. Patient #9 had a mask applied to his/her face, however the mask failed to cover the patient’s chin, creating pockets where his/her breath could escape during the CVC disconnection process. Further observation identified Staff Person #2’s mask was improperly donned, covering only the very tip of his/her nose and leaving his/her nostrils partially exposed for the duration of the disconnection process (which included removing the dialysis lines from each arm of the CVC, flushing each arm of the CVC with normal saline, and the instilling heparin into each arm of the CVC). 2. Patient #4 had diagnoses that included end stage renal disease. Review of physician’s orders directed in-center hemodialysis treatments three times weekly for three (3) hours and forty (40) minutes with a 4.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 600 milliliters, using a central venous catheter in the upper right chest. Observation made on 1/22/25 at 2:30 PM identified Patient #4 had completed his/her dialysis treatment and was being disconnected from the dialysis machine. Patient #4 had his/mask applied appropriately, covering the bridge of his/her nose to around his/her chin, however Staff Person #5 had his/her mask just covering the tip of his/her nose, leaving his/her nostrils partially exposed for the duration of the disconnection process (which included removing the dialysis lines from each arm of the CVC, flushing each arm of the CVC with normal saline, and the instilling heparin into each arm of the CVC). Interview with the Group Facility Administrator (GFA) on 1/22/25 at 4:03 PM identified face masks were to be worn with all CVC put on and take offs and throughout each process. The GFA further indicated proper application of the face mask should cover the bridge of the nose to under the chin to prevent cross contamination. Review of the Central Venous Catheter with Clearguard Hemodialysis Antimicrobial End Caps Procedure directed the teammate and patient to wear masks covering the nose and mouth during the discontinuation of dialysis procedure.”

“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: 47640 1. Based on observation during tour on 01/21/25 at 11:00 AM, while accompanied by the Bio-Medical Technician and the Facilities Administrator, the facility failed to maintain a safe, functional and comfortable environment to ensure the safety of the patients, the staff and the public. The findings include the following: a. A cart and a patient lift that was on the treatment floor has rusted casters, not allowing a cleanable surface as required by the “CT Public Health Code”. 2. Based on observation during tour on 01/24/25 at 11:00 AM of the HOME hemodialysis area while accompanied by the Interim Bio-Medical Technician and the Regional Operations Director, the facility failed to maintain a safe, functional and comfortable environment to ensure the safety of the patients, the staff and the public. The findings include the following: a. There was visible staining and discoloration if the millwork and supports of the millwork under the drain box of stations #4 & #5, not providing a cleanable surface as required by the “CT Public Health 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: 47640 Based on observation during tour on 01/21/25 at 11:00 AM, while accompanied by the Bio-Medical Technician and the Facilities Administrator, the facility failed to maintain a building that was constructed and maintained to ensure the safety of the patients, the staff and the public. The findings include the following: The fire door to the conference room was being held open by a plastic wedge and the latch to the door was taped over not allowing the door to positively latch, negating the doors ability to resist the passage of smoke and fire as required by Section #5.2 of the 2010 Edition of NFPA 80.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 47640 Based on a documentation review on 01/21/25 at 11:00 AM, the facility failed to maintain a building that was constructed and maintained to ensure the safety of the patients, the staff and the public. The findings include the following: a. The facility failed to provide documentation to indicate that the sprinkler system was inspected in the 4th quarter of 2024 as required by Section 5.1.1.2 of the 2011 edition of NFPA 25. b. The facility failed to provide documentation to indicate that a sensitivity test of the facility’s smoke detection system was completed within the last two (2) years as required by Section 14.4.5.3.2 of the 2010 edition of NFPA 72. c. The facility failed to provide documentation to indicate that a fuel analysis of the generators’ fuel was conducted within the past twelve (12) months as required by Section 8.3.8 of the 2010 edition of NFPA 110.”

“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 review of clinical records, interview, and review of facility documentation for four (4) of four (4) patients (Patient #2, #4, #6, and #8) reviewed for dialysis treatments, the facility failed to ensure that changes to prescribed blood flow rates and dialysate flow rates were noted in the patient’s electronic medical record. The findings included: 1. Patient #4 had diagnoses that included end stage renal disease. Review of physician’s orders directed in-center hemodialysis treatments three (3) times weekly for three (3) hours and forty (40) minutes with a 4.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 600 milliliters, using a central venous catheter in the upper right chest. Review of Patient #4’s treatment flow sheets identified the following: a. Treatment dated 12/22/24 identified a BFR of 370 for one (1) hour and sixteen (16) minutes of treatment without notation of the reason for the decreased BFR. b. Treatment dated 12/24/24 identified a BFR of 350 for one (1) hour of treatment without notation of the reason for the decreased BFR. c. Treatment dated 1/3/25 identified a BFR of 350 for one (1) hour and twenty-five (25) minutes of treatment without notation of the reason for the decreased BFR. 2. Patient #6 had diagnoses that included end stage renal disease. Review of physician’s orders directed in-center hemodialysis treatments three (3) times weekly for three (3) hours with a 3.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 500 milliliters, using a central venous catheter in the left internal jugular vein. Review of Patient #6’s treatment flow sheets identified the following: a. Treatment dated 1/2/25 identified a BFR of 370 for ninety (90) minutes and a DFR of 610 for two (2) hours and twenty-nine (29) minutes without notation of the reason for the decreased BFR and increased DFR. b. Treatment dated 1/20/25 identified a BFR of 360 for forty-nine (49) minutes without notation of the reason for the decreased BFR. 3. Patient #8 had diagnoses that included end stage renal disease. Review of physician’s orders directed in-center hemodialysis treatments three (3) times weekly for four (4) hours with a 2.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 800 milliliters, using a central venous catheter in the right chest. a. Treatment dated 12/23/24 identified a BFR of 350 for the entire treatment without notation of the reason for the decreased BFR. b. Treatment dated 12/23/24 identified a BFR of 350 for the entire treatment without notation of the reason for the decreased BFR. Interview with the Manager of Clinical Services on 1/22/25 at 3:39 PM identified facility practice was to notate the reason why the BFR and/or DFR was modified during a patient’s treatment and for staff to notify the physician is a patient was not able to attain the prescribed BFR/DFR. Review of the Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment policy identified if the dialysis prescription is not being met (including dialysis flow rate) the reason will be documented and the licensed nurse informed.”

“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: 47491 Based on review of clinical records, interview, and review of facility documentation for one (3) of four (4) patients (Patient #4, #6, and #8) reviewed for dialysis treatments, the facility failed to notify the registered nurse when a patient’s systolic blood pressure dropped below ninety (90). The findings included: 1. Patient #4 had diagnoses that included end stage renal disease. Review of physician’s orders directed in-center hemodialysis treatments three (3) times weekly for three (3) hours and forty (40) minutes with a 4.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 600 milliliters, using a central venous catheter in the upper right chest. Review of Patient #4’s 1/13/25 treatment record identified a sitting blood pressure of 168/49 during pre-treatment assessment. A sitting blood pressure of 87/54 was obtained when treatment was initiated at 11:45 AM (an 81 point drop in systolic blood pressure when compared to the pre-treatment blood pressure of 169/49) and was noted by the patient care technician (PCT). Further review of the 1/13/25 treatment record identified another blood pressure of 87/43 was obtained at 11:50 AM and was noted by a PCT, however both notations failed to indicate the registered nurse was informed of Patient #4’s low blood pressure. Patient #4’s blood pressure was retaken at 11:52 AM and registered at 97/39 (a 72 point drop in systolic blood pressure when compared to the pre-treatment blood pressure of 169/49). 2. Patient #6 had diagnoses that included end stage renal disease. Review of physician’s orders directed in-center hemodialysis treatments three (3) times weekly for three (3) hours with a 3.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 500 milliliters, using a central venous catheter in the left internal jugular vein. Review of Patient #6’s 1/18/24’s treatment record identified a drop in systolic blood pressure from 128/53 (at the initiation of treatment) at 11:16 AM to 89/54 at 11:32 AM, then increased to 96/24 at 11:34 AM, then dropped again to 89/26 at 11:36 AM and 87/44 at 11:38 AM, all without notation that the registered nurse was informed of Patient #6’s low blood pressures. Patient #6’s blood pressure improved to 96/34 at 11:40 AM. 3. Patient #8 had diagnoses that included end stage renal disease. Review of physician’s orders directed in-center hemodialysis treatments three (3) times weekly for four (4) hours with a 2.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 800 milliliters, using a central venous catheter in the right chest. Review of Patient #8’s 1/18/25 treatment record identified blood pressure of 156/99 at the initiation of treatment at 11:27 AM. Further review of the treatment record identified a drop in blood pressure from 156/136 obtained at 11:33 AM to 92/49 at 11:35 AM without a recheck of the 11:35 AM blood pressure or notation the registered nurse was informed of the drop in blood pressure. The next blood pressure obtained was 147/120 a 12:03 PM. Interview with the Manager of Clinical Services on 1/22/25 at 3:37 PM identified significant drops in systolic blood pressure should precipitate a blood pressure recheck and registered nurse notification. Review of the Pre-Intra-Post Treatment Data Collection , Monitoring, and Nursing Assessment policy identified an intradialytic systolic blood pressure of less than 90 should be reported immediately to the licensed nurse.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 44675 Based on interview and review of facility policy for three (3) of five (5) Patients (Patient #15, #16, and #18), reviewed for tuberculosis, the facility failed complete tuberculosis monitoring and testing per facility policy. The finding included: 1. Patient #15 was admitted with diagnoses that included End Stage Renal Disease (ESRD). Review of the physician’s orders directed hemodialysis three (3) times a week for four (4) hours with a left femoral central venous catheter (CVC). Review of Patient #15’s Tuberculosis Risk Assessment Questionnaire (TB RAQ) dated 9/30/22 identified Patient #15 had no symptoms. Review of Patient #15’s medical record since admission identified Patient #15 had no TST tests or chest x-rays on file. 2. Patient #16 was admitted to the facility on 6/22/24 with diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three (3) times a week for three (3) hours and thirty (30) minutes with a right central venous catheter (CVC). Review of Patient #16’s tuberculosis risk assessment questionnaire (TB RAQ) dated 7/24/24 identified Patient #16 had no symptoms. Review of Patient #16’s medical record since admission identified Patient #15 had no TST tests (TST; a type of test which helps diagnose a tuberculosis infection) or chest x-rays on file. 3. Patient #18 was admitted to the facility on 7/11/23 with diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three times a week for three (3) hours and fifteen (15) minutes with a left upper arteriovenous fistula (AVF). Review of Patient #18’s medical record identified Patient #18 had a chest x-ray completed on 6/27/23 (prior to admission to the facility). Patient #18 did not have a tuberculosis risk assessment questionnaire (TB RAQ) and tuberculin skin test tests on file for admission. Review of Patient #18’s tuberculosis risk assessment questionnaire (TB RAQ) dated 10/5/24 identified Patient #18 had no symptoms. Review of Patient #18’s medical record since admission identified Patient #18 had no TST tests or chest x-rays (since 6/27/23) on file. Interview with the Charge Nurse on 1/24/25 at 1:00 PM identified she was not aware that patients needed any tuberculosis testing completed or on file in the dialysis clinic. She identified she has never done annual tuberculosis testing and was not aware she had too. She identified as a charge nurse responsible for the daily operations, it can be difficult to review clinical records as there are daily tasks/patients needs that have to be completed. Interview with the FA on 1/24/25 on 12:45 PM identified she was not aware tuberculosis monitoring and testing was not being completed. She identified she reached out to the Skilled Nursing Facility that services the dialysis den and identified Patient #15’s TST was last done 9/30/22 (outdated) and Patient #18’s TST was last done 7/22/23 (outdated). She identified Dialysis Dens do not have a clinical coordinator that oversees the patients’ medical records and care. She identified there are two charge nurses in the facility (that work on different days). She identified there is not a vaccination manager, but it is the responsibility of the charge nurse to review the clinical records for the patients she is taking care of on that shift (includes completing plan of cares, reviewing lab results, reviewing vaccination, etc.). She identified for the patients who tuberculosis tests are outdated; they will be completed on the next treatment. She identified going forward a tuberculosis testing binder will be made and reviewed by the RN every month to see who is due for testing and ensure they are tested prior to the expiration date. If a patient requires a chest x-ray, the CN will coordinate with the nursing home to schedule an appointment. Review of the tuberculosis infection control policy directed for an admission new to dialysis with a chest x-ray completed within three months prior to the first treatment, administer a two-step TST (tuberculin skin test) on admission (initial TST with a second TST repeated one to three weeks after the first). If the second TST is negative, the patient will participate in annual screening using a one-step TST. A TB RAQ will be administered on admission and annually.”

“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 one (1) of five (5) home hemodialysis patients reviewed for anemia (Patient #3), the facility failed to monitor the patients anemia bloodwork and administer medications in accordance to physician’s orders . The findings include the following: 1. Patient #3 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 arteriovenous fistula (AVF) and an estimated dry weight (EDW) of 44 kg. Review of the physician’s labs orders directed venofer once a month and hemoglobin twice a month. The stable care plan dated 6/22/23 identified Patient #3’s hemoglobin was in range. A physician’s order dated 2/23/24 - 10/27/24 directed Venofer (iron) 50 mg once a week. A physician’s order dated 9/30/24 - 10/27/24 directed Mircera (increases red blood cell production) 30 mcg every four weeks. Review of Patient #3’s medication administration identified Patient #3 last received 30 mcg of Mircera on 10/3/24 and 50 mg of Venofer on 10/8/24. Review of Patient #3’s labs identified on 10/22/24 Patient #3’s hemoglobin was 11.1 (expected lab range 10-12). The facility failed to ensure two hemoglobin’s were drawn during the month of October 2024 per physician’s orders. Patient #3’s iron was 36 (expected lab range 60 -170). A nursing note dated 10/22/24 identified Patient #3 had a fall at home and was discharged to the facility’s dialysis den (nursing home with a dialysis unit attached) for rehabilitation. Review of Patient #3’s medical record failed to identify and hemoglobin and iron labs were drawn and reviewed during the month of November 2024. A nursing note dated 11/27/24 identified Patient #3 was discharged from the dialysis den to home and returned to the out-patient dialysis facility. Review of Patient #3’s labs identified on 12/3/24 Patient #3’s hemoglobin was 9.1 (2.8 point decrease since last lab). Patient #3’s iron was 26 (10 point decrease since last lab). A physician’s order dated 12/6/24 to present directed Venofer 50 mg once a week. A physician’s order dated 12/5/24 - 1/7/25 directed Mircera 60 mcg every two weeks. Review of Patient #3’s medication administration identified Patient #3 received 60 mcg of Mircera on 12/7/24 and 50 mg of Venofer on 12/7/24. Review of Patient #3’s medication administration identified Patient #3 was not administered Mircera between 10/3/24 and 12/7/24 and was not administered Venofer between 10/8/24 and 12/7/24. Interview with the Manger of Clinical Services on 1/22/25 at 2:30 PM identified hemoglobin’s should be drawn twice a month and iron drawn once a month. She identified the facility missed an opportunity to draw Patient #3’s hemoglobin in October 2024. She identified Patient #3 did not have any hospitalizations in November 2024. She identified there was no note in the medical record as to why labs were not drawn in November and would expect there to be. She identified the dialysis den should have drawn two hemoglobin labs and one iron lab in November 2024. Interview with the Manager of Clinical Services for the dialysis den on 1/24/25 at 3:00 PM identified Patient #3 should have had admission labs and hemoglobin labs twice in the month. He identified when a patient is transferred to the dialysis den from another clinic under the same company, the staff enter the patient’s previous orders. He identified Patient #3’s Mircera and Venofer orders should have been ordered in the dialysis den. He further identified it is the responsibility of the facility staff to review laboratory results as they result. Interview with the Medical Director of the dialysis den (Patient #3’s physician) on 1/9/25 at 3:00 PM identified for a transfer from the same company to the dialysis den, the nurse should carry over all the orders (including prescription and medications) and enter into their facility orders. She identified this way medications can be given before the labs results. She identified Patient #3 should have received Mircera and Venofer when attending the dialysis den. She identified there have been RN turnover and the nurse who entered Patient #3’s orders may not have entered all of Patient #3’s orders on admission. She identified there was also issues with the laboratory in Florida where the labs are sent due to weather and the holiday causing errors in the second draw of the month. She identified there is the option for stat labs and to ask the nursing home to draw labs if needed.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 44675 Based on observation, review of clinical records, interview, and policy review for two (2) of three (3) home hemodialysis patients observed for vascular access (Patient #20 and #21), the facility failed to ensure post treatment hemostasis was achieved and a new dressing applied to the access site per facility policy. The findings include the following: Observation conducted on 1/24/25 at 9:58 AM identified Patient #20 had a taped gauze and clamp on his/her left upper arteriovenous graft (AVG) after hemodialysis treatment. Staff Person #3 removed the clamp and taped heavily over the gauze without removing the gauze, checking for hemostasis and applying a new, clean gauze. Observation conducted on 1/24/25 at 1:40 PM identified Patient #21 had a taped gauze and clamp on his/her left upper arteriovenous fistula (AVF) after hemodialysis treatment. Staff Person #3 removed the clamp and taped heavily over the gauze without removing the gauze, checking for hemostasis and applying a new, clean gauze. Interview and policy review with the Manager of Clinical Services for the home dialysis on 1/24/25 at 2:00 PM identified according to policy, staff should remove the previous gauze used to hold the site, ensure hemostasis has been achieved and replace with a dressing. Review of the post dialysis vascular access care policy directed once bleeding has stopped, discard gauze or bandaid used to hold the site. Inspect site for any trauma and for hemostasis. Apply a bandaid type or sterile dressing over the cannulation site. If a sterile dressing is used, apply tape lightly.”

“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 clinical record review, interview and review of facility policy for one (1) of five (5) Patients (Patient #19), reviewed for prescription compliance, the facility failed to address an irregular vital sign pre-treatment per facility policy, for one (1) of four (4) patients (Patient #4) reviewed for physician’s orders, the facility failed to obtain a physician’s order when holding a nutritional supplement twice within the same month, for two (2) of four (4) patients (Patient #4 and #6) reviewed for dialysis treatments, the facility failed to complete post-treatment assessments, and for two (2) of four (4) patients, the facility failed to complete vitals in accordance with facility policy. The findings included: 1. Patient #19 was admitted to the facility with diagnoses that included end stage renal disease. Patient #19’s physician orders included hemodialysis treatment three (3) times a week for three (3) hours and thirty (30) minutes with a left upper arteriovenous graft (AVG). Patient #19 did not have specific physician parameters in his/her orders for blood pressure and heart rate ranges. Review of Patient #19’s hemodialysis flowsheets identified the following: a. On 5/14/24 Patient #19’s pre-treatment heart rate was 105 Beats Per Minute (BPM)(stable range is 60 - 100 BPM) at 10:25 AM. Treatment was initiated at 10:33 AM by an LPN and identified Patient #19’s heart rate was 104 BPM and was signed off by the LPN with no documentation that the RN was notified. At 11:00 AM Patient #19’s heart rate was 109 BPM and was signed off by the PCT with no documentation that the RN was notified. At 12:28 PM the RN nursing assessment was completed (two hours after treatment initiation) and identified that although Patient #19’s pulse was 105 BPM, she identified Patient #19’s heart was of regular rate and rhythm. b. On 5/16/24 Patient #19’s pre-treatment heart rate was 112 BPM at 9:40 AM. Treatment was initiated at 9:38 AM by an LPN and identified Patient #19’s heart rate was 111 BPM and was signed off by the LPN with no documentation that the RN was notified. At 10:00 AM Patient #19’s heart rate was 113 BPM and was signed off by the LPN with no documentation that the RN was notified. At 10:08 AM the RN nursing assessment was completed (after treatment initiation) and identified that although Patient #19’s pulse was 112 BPM, she identified Patient #19’s heart was of regular rate and rhythm. Interview with the Manger of Clinical Services for the facility’s dialysis den on 1/24/25 at 2:22 PM identified abnormal findings should be communicated to the RN before treatment initiation. A heart rate greater than 100 BPM would be abnormal. If a patient has a baseline of a rapid heart rate, parameters ordered by the physician should be put in the patients treatment orders. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed that the licensed nurse will round on patients without reported abnormal findings and complete the nursing assessment within one (1) hours of dialysis treatment initiation or sooner as required by state law. It directed any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “abnormal findings” section of this policy. If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. The abnormal findings section of the policy directed an abnormal finding pre-treatment for fluid status would be any weight loss from the last post weight. An abnormal finding pre/intra/post treatment for heart or pulse would be less than sixty (60) BPM or greater than one hundred (100) BPM. 2. Patient #4 had diagnoses that included End Stage Renal Disease. Review of physician’s orders directed in-center hemodialysis treatments three (3) times weekly for three (3) hours and forty (40) minutes with a 4.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 600 milliliters, using a central venous catheter in the upper right chest, and administration of 377 milliliters of IDPN (intradialytic parenteral nutrition) with each treatment. Review of Patient #4’s lab results identified albumin levels of 2.7 on 10/22/24, 2.8 on 11/20/24, and 2.9 on 12/18/24. Review of treatment records dated 1/13/25 and 1/15/25 failed to identify Patient #4 was administered IDPN during treatment and had adequacy labs drawn. Interview with the Group Facility Administrator (GFA) on 1/22/25 at 3:43 PM identified IDPN was sometimes held when testing for adequacy testing if the patient did not pass the previous adequacy test drawn within the same month. However, the GFA failed to provide a physician’s order authorizing the nutritional supplement could be held on both 1/13/25 and 1/15/25. Interview with the Manager of Clinical Services on 1/22/25 at 3:44 PM identified if IDPN was to be held, a physician’s order should have been obtained stating why it was on hold and the reason for not administering it. 3. a. Patient #4 had diagnoses that included ESRD. Review of physician’s orders directed in-center hemodialysis treatments three (3) times weekly for three (3) hours and forty (40) minutes with a 4.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 600 milliliters, using a central venous catheter in the upper right chest. Review of Patient #4’s 12/31/24 treatment record failed to identify that a post-treatment assessment was completed. b. Patient #6 had diagnoses that included ESRD. Review of physician’s orders directed in-center hemodialysis treatments three times weekly for three (3) hours with a 3.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 500 milliliters, using a central venous catheter in the left internal jugular vein. Review of Patient #6’s 12/26/24 treatment records failed to identify a post-treatment assessment was completed. Interview with the Manager of Clinical Services on 1/22/25 at 3:46 PM identified all patients are to be assessed following treatment prior to exiting the clinic. 4. a. Patient #4 had diagnoses that included end stage renal disease. Review of physician’s orders directed in-center hemodialysis treatments three times weekly for three (3) hours and forty (40) minutes with a 4.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 600 milliliters, using a central venous catheter in the upper right chest. Review of Patient #4’s 12/31/24 treatment records failed to identify to identify a thirty (30) minute vital was obtained between 12:03 PM and 1:07 PM b. Patient #8 had diagnoses that included end stage renal disease. Review of physician’s orders directed in-center hemodialysis treatments three times weekly for four (4) hours with a 2.0 potassium/2.5 calcium bath, run at a blood flow rate (BFR) of 400 milliliters and dialysate flow rate (DFR) of 800 milliliters, using a central venous catheter in the right chest. Review of Patient #8’s 1/7/25 treatment record failed to identify thirty (30) minute vitals were obtained between 11:57 AM and 1:27 PM. Interview with the GFA on 1/22/25 at 3:59 PM identified vitals were to be collected and reviewed at least every thirty (30) minutes while a patient is receiving dialysis treatment. Review of the Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment directed vital signs and treatment monitoring were to be completed at least every thirty (30) minutes.”