Davita Salem Northeast 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: 37700 Based on observation, interview and policy review, the facility failed to ensure that 1 staff member, (Patient Care Technician [PCT] #1) performed hand hygiene when changing gloves to reduce the risk of infection and cross contamination when providing patient care. Findings include: Review of the facility policy, titled Infection Control for Dialysis Facilities, revised April 2023, included the following: *All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene: prior to gloving and immediately after removal of gloves. On 2/20/24 at 11:14 A.M., the surveyor observed PCT #1 perform exit site care and initiate dialysis treatment for Patient #10 via a Central Venous Catheter (CVC). PCT #1 started with the exit site care. PCT #1 removed the old dressing and discarded it. He removed his gloves, and without performing hand hygiene put on a new pair of gloves and placed a clean field under the limbs of the CVC. During an interview on 2/20/24 at 2:00 P.M., PCT #1 said hands should be cleansed prior to putting on new gloves but he could not recall if he had performed hand hygiene to his hands prior to putting on a new pair of gloves.”

“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: 30889 Based on observation, policy review and staff interview, the facility failed to ensure that PPE (Personal Protective Equipment), such as gowns were removed properly after caring for a patient on Clostridium Difficile (C.diff) [C.diff is a bacteria that causes diarrhea which can be life threatening and is easily spread from person to person] precautions to protect against potential spread of infection. Findings include: Review of the facility policy entitled, Clostridioides Difficile (C.diff) Management, last revised 10/2023, included the following: Transmission Based Precautions: Gown: Separate long-sleeved garment that is removed and discarded after caring for the patient. Review of the Daily Assignment sheet, dated 2/20/24, indicated the patient receiving his/her dialysis at station 21 was on precautions due to a C.diff infection. During an observation on 2/20/24 at 3:00 P.M.. the surveyor observed Patient Care Technician (PCT )#1 as he completed the termination of dialysis for a patient on precautions for C.diff as well as disinfection of the hemodialysis machine and chair at station 21. Once PCT #1 completed these tasks he picked up 2 bottles of acetic acid which touched his gown and brought them into station 13 while another patient was receiving treatment. PCT #1 then went to station 14 and reinforced a dressing to a patient’s arm. PCT #1 did not remove the gown he wore while caring for the patient with C.diff in station 21. During an interview on 2/20/24 at 3:15 P.M., PCT #1 said that the patient in station 21 was on precautions for C.diff . PCT #1 said he didn’t know he needed to change his gown after caring for a patient on precautions for C.diff.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 37700 Based on observation, interview and policy review, the facility failed to ensure there was a separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to ensure, 1.) 1 of 2 staff (Registered Nurse [RN] #2) observed, failed to remove potentially contaminated personal protective equipment (PPE) gowns and a faceshield before preparing intravenous medication and 2.) 1 staff (Patient Care Technician [PCT] #1) observed, failed to remove a rolling trash bin from the treatment area where Patient #10 was receiving a dialysis treatment. Findings Include: Review of the Centers for Disease Control (CDC) Infection Control Requirements for Dialysis Facilities and Clarification Regarding Guidance on Parenteral Medication Vials, dated 8/15/08, included the following: CDC recommends that all parenteral medications should be prepared in a clean area separate from potentially contaminated items and surfaces. In hemodialysis settings where environmental surfaces and medical supplies are subjected to frequent blood contamination, medication preparation should occur in a clean area removed from the patient treatment area. Proper infection control practices must be followed during the preparation and administration of injected medications. This is consistent with official CDC recommendations for infection control precautions in hemodialysis. Review of the facility policy, titled Infection Control for Dialysis, revised April 2023, included the following: *Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. 1. On 2/22/24 at 12:36 P.M., during observation of medication preparation and administration, the surveyor observed RN #2 enter the medication preparation area (labeled clean) wearing a gown and faceshield that had been worn in and out of patient stations to care for patients. At no time did RN #2 remove the gown and faceshield prior to entering the medication preparation area. She aseptically removed one pre-filled syringe of Micera (used to treat anemia associated with chronic kidney disease) 100 micrograms (mcg), she prepared the Micera 100 mcg and then proceeded to administer the medication to a patient at station #4. During an interview on 2/22/24 at 12:50 P.M., RN #2 said she should have not worn her gown and faceshield while preparing medication for administration in the medication prep area. She further said she should have donned (put on) a new gown and faceshield prior to administering the medication. 2. On 2/20/24 at 11:14 A.M., the surveyor observed PCT #1 initiate a dialysis treatment via a Central Venous Catheter (CVC) for Patient #10 at Station #21. A rolling trash bin, with an opening in the lid, was observed to be in the treatment area. PCT #1 did not move the trash bin away from the dialysis chair thereby increasing chance of cross contamination of a clean area. During an interview on 2/20/24 at 11:25 A.M., Registered Nurse #5 said the trash bin should not have been located in such close proximity to Patient #10 and she moved the trash bin further away from Station #21.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 30889 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 3 staff observed (Patient Care Technician (PCT) #1), adequately cleaned and disinfected contaminated surfaces within the dialysis station after a patient on precautions for Clostridium difficile (C. diff) [C.diff is a bacteria that causes diarrhea which can be life threatening and is easily spread from person to person] finished his/her treatment. Findings include: Review of the facility policy entitled, Clostridioides Difficile (C.diff) Management, last revised 10/2023, included the following: Transmission Based Precautions: Disinfection-1:10 bleach solution with approximate total contact time of 10 minutes, this will require repeating application and subsequent drying steps two additional times (three (3) total applications). Review of the Daily Assignment sheet, dated 2/20/24, indicated the patient receiving his/her dialysis at station #21 was on precautions due to a C.diff infection. During an observation on 2/20/24 at 3:00 P.M., the surveyor observed PCT #1 as he prepared to disinfect station #21 after a patient with C.diff had received treatment. PCT #1 submerged several white disposable cloths into the container labeled 1:100 bleach solution (not 1:10 bleach solution per the facility policy) and he began wiping down the hemodialysis machine and the hemodialysis chair with the 1:100 bleach wipes. Once he wiped down both areas he discarded the bleach wipes and performed hand hygiene using a hand sanitizer and left the station to care for another patient. PCT #1 did not use 1:10 bleach wipes and he did not disinfect the hemodialysis machine or the hemodialysis chair two additional times for a total of 3 applications. During an interview on 2/20/24 at 3:15 P.M., PCT #1 said that the patient in station #21 was on precautions for C.diff . PCT #1 said he didn’t know he needed to use 1:10 bleach wipes or that he needed to repeat the process for a total of three times.”

“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: 37349 Based on policy review, record review, and interview, the facility failed to ensure timely administration of the hepatitis B vaccine series for 3 out of 3 applicable susceptible patients (#1, #2 and #3), out of 10 patient records reviewed for a total sample of 12 patients. Findings include: Review of the facility policy, entitled Hepatitis B Surveillance,Vaccination, Infection Control Measures, and Isolation Guidance, revised 10/23, included the following: *Purpose: To prevent the spread of hepatitis B infections in the dialysis setting. *Hepatitis Vaccination: an order will be obtained for hepatitis B Vaccination. The patient is provided the Vaccination Information Sheet (VIS) and a consent form (included in Patient Registration Packet found in Reggie). The patient will consent to the vaccination or decline. The completed form will be kept in the patient’s health record. 1. For Patient #1, admitted to the facility in 4/2021 with a diagnosis of End Stage Renal Disease and susceptible to the hepatitis B virus, the facility failed to administer the hepatitis B vaccine in a timely manner. Review of the medical record indicated that Patient #1 was susceptible to the hepatitis B virus with an antibody of 3 on 3/6/23 (less than 10 indicates patient is susceptible). The medical record failed to indicate that Patient #1 had received the hepatitis B vaccine. The medical record also failed to indicate that the vaccine had been offered and declined. During an interview on 2/21/24 at 11:50 A.M., the Facility Administrator said that Patient #1 was susceptible to the hepatitis B virus and should have been offered the hepatitis B vaccine. She said there was no evidence in the medical record that Patient #1 had been vaccinated or had been offered the vaccine and declined. 2. For Patient #3, admitted to the facility in 11/2023 with a diagnosis of End Stage Renal Disease and susceptible to the hepatitis B virus, the facility failed to administer the hepatitis B vaccine in a timely manner. Review of the medical record indicated that Patient #3 was susceptible to the hepatitis B virus with an antibody of less than 3 on 1/18/24 (less than 10 indicates patient is susceptible). The medical record contained a consent to receive the vaccine, dated 11/3/23. The medical record failed to indicate that Patient #3 had received the hepatitis B vaccine. During an interview on 2/21/24 at 2:00 P.M., the Regional Home Therapies Manager said that susceptible patients should be offered the hepatitis B vaccine. She said Patient #3 was susceptible to the hepatitis B virus and chose to receive the vaccine in 11/2023. She said Patient #3 should have received the first dose in December 2023. 44223 3. For Patient #2, admitted to the facility in 3/2023 with a diagnosis of End Stage Renal Disease and susceptible to the hepatitis B virus, the facility failed to administer the hepatitis B vaccine in a timely manner. Review of the medical record indicated that Patient #2 was susceptible to the hepatitis B virus with an antibody of less than 3 on 2/5/24 (less than 10 indicates patient is susceptible). The medical record did not have any documented evidence to indicate that the vaccine had been offered and declined. During an interview on 2/21/24 at 12:00 P.M., the Facility Administrator (FA) said that Patient #2 should have been offered the hepatitis B vaccine. She said there was no indication in the medical record or in the computer that Patient #2 had been offered the hepatitis B vaccine. The FA said she did not believe it had been completed.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 37700 Based on observation, interview, and policy review, the facility failed to ensure that 1 staff member, Patient Care Technician (PCT) #1 observed, provided adequate infection control measures during the initiation of dialysis treatment with a Central Venous Catheter (CVC) relative to proper cleansing of the CVC exit site and hubs for 1 of 2 applicable patients (#8) observed out of a total sample of 12 patients. Review of the facility policy titled, Central Venous Catheter with Clearguard HD Antimicrobial End Caps Procedure, revised October 2023, included the following: *Holding catheter with the non-dominant hand and using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds, apply to the CVC exit site in a “back and forth” pattern, using gentle friction progressing from the insertion site to the periphery using both sides of the swab. If site is not free of exudates, repeat this step with new 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab. Then wait 60 seconds for air dry time. *Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub for 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any residue, for example blood. Effective dry time is 60 seconds. Hold the limbs until the antiseptic has dried. *Attach sterile 10 milliliter (ml) syringes to the arterial and venous limbs. On 2/20/24 at 11:14 A.M., the surveyor observed PCT #1 initiate dialysis treatment with a CVC for Patient #8. While cleansing the CVC exit site, PCT #1 used a Chloraprep swabstick and in an up and down movement cleansed the area above the exit site and then the sides of the CVC. He cleansed the CVC exit site area for 18 seconds. He did not wait for the area to dry for 60 seconds but continued with the procedure. The surveyor observed PCT #1 disinfect each CVC hub with a new alcohol prep pad. He cleansed the red hub by encircling the hub with an alcohol pad for 2 seconds. He cleansed the blue hub by encircling the blue hub with an alcohol pad for 5 seconds. He did not scrub each hub including the sides, threads and ends of the hubs thoroughly with friction. He did not hold the limbs and wait for the antiseptic to dry for 60 seconds but continued with the procedure by attaching sterile syringes to the arterial and venous limbs. During an interview on 2/20/24 at 2:00 P.M., PCT #1 said he thought he provided adequate cleansing of the CVC exit site and the CVC hubs. During an interview on 2/21/24 at 2:00 P.M., the Facility Administrator (FA) said CVC exit site care should include cleansing for 30 seconds and waiting 60 seconds for skin to dry. She further said the CVC hubs should be scrubbed for 15 seconds and to let air dry. She said PCT #1 did not follow the facility procedure for initiation of dialysis treatment with a CVC, as required.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 31240 Based on interview, chlorine testing log review, and policy review, the facility failed to ensure staff conducted water testing relative to chlorine, according to the facility policy. Findings include: Review of the facility policy, entitled Daily Water System Total Chlorine Monitoring, dated October 2023, included the following: *Total chlorine testing is done on a daily basis prior to the first patient treatment and within every 4 hours until all activities that require use of dialysis quality water are completed. All samples are to be drawn only after the water system has been operating for at least 15 minutes. Document the results on the Routine Total Chlorine Testing Log and in IT Clinical System. Administrative staff indicated, (during the entrance conference), that the facility’s hours of operation were from 6:00 A.M. through 9:00 P.M., Monday through Saturday, which allowed for 3 shifts of dialysis treatments daily. Review of the Routine Total Chlorine Testing Logs for November 2023 and December 2023 indicated the following days when staff did not conduct and document chlorine testing during the last shift of treatment (approximately 4:00 P.M.): *11/27/23 *12/5/23 During an interview on 2/21/24 at 1:00 P.M., the Regional Biomedical Director said, after reviewing the findings with the Biomedical Technician, the chlorine testing is done 5 times a day, and was missing during the last shift on 11/27/23 and 12/5/23. During an interview on 2/21/24 at 1:45 P.M., Patient Care Technician (PCT) #1 and PCT #3 said chlorine testing is done first thing in the morning and then every 4 hours. They said the results are documented on the logs in the water room.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 31240 Based on observation, document review, policy review and interview, the facility failed to 1.) conduct daily equipment calibration relative to pHoenix meters used to test the pH of dialysate solution, and 2.) ensure 1 of 2 staff members (Patient Care Technician [PCT] ) # 3, followed the facility policy related to rinsing the pHoenix meter between dialysate samples. Findings include: 1. Review of the facility’s pHoenix Meter Level 1 Calibration policy, dated September 2015, indicated the following: * Level 1 calibration is completed by a trained teammate daily. * If meter does not calibrate within specifications for pH, do not use meter and contact Biomed for service. * Document the completion of the calibration on the pHoenix Meter Level 1 Calibration Log. Review of the facility’s pHoenix Meter Level 1 Calibration Log form, indicated the following: * Meter calibration should be verified prior to first use each day or if inaccurate readings are suspected. Review of the December 2023 pHoenix Meter Log indicated the pH calibration was not conducted for 2 of 2 meters on 12/1/23 and 12/2/23. Review of the January 2024 pHoenix Meter Log indicated the pH calibration was not conducted for 2 of 2 meters on 1/11/24 and 1/20/24. During an interview on 2/21/24 at 10:30 A.M., the Regional Biomedical Director said the pHoenix meters are calibrated daily on days of operation, and staff are required to document the testing on the log. At 1:00 P.M., he said, after speaking to the facility’s Biomedical Technician, staff had not notified him that the meters were not working, so staff should have conducted the calibration on the days noted above. 37349 2. The facility failed to ensure that 1 of 2 staff members (Patient Care Technician [PCT] #3), followed the facility policy related to rinsing the pHoenix meter between dialysate samples. Review of the facility policy, entitled Measuring Conductivity, Temperature and/or pH using the pHoenix Conductivity Meter, revised April 2022, included the following: * When you are finished with the pHoenix meter, RINSE interior thoroughly with dialysis quality water. On 2/21/24 at 9:50 A.M., the surveyor observed PCT #3 use the pHoenix meter to test the pH of a dialysate sample from station #18. When she was finished with the meter she returned it without rinsing the interior of the meter. During an interview on 2/21/24 at 9:55 A.M., PCT #3 said there is no need to rinse the meter between samples. During an interview on 2/21/24 at 10:05 A.M., the Regional Biomedical Director said the policy is to rinse the meter between samples.”

“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: 44223 Based on observation and staff interview, the facility failed to maintain a safe environment for patients, staff, and the public as evidenced by, 1.) the entrance door to the treatment floor being propped open, allowing direct access to the treatment floor from the lobby area without supervision from staff and 2.) the entrance door to staff areas was unsecured, allowing direct access to staff offices, supply areas, and the treatment area with out supervision from staff. On 2/20/24 at 7:30 A.M., the surveyor entered the dialysis facility lobby and observed the door to the treatment floor was propped open with a wet floor sign. Upon observation the surveyor noted there was no staff in the immediate area and there was no receptionist at the reception desk. The open door allowed for direct access to the treatment floor by anyone entering the facility from the outside. The door was observed to have a sign on it that said keep door closed at all times. Further observation of the lobby indicated an access door to the back of the facility leading to staff office, supply areas and the treatment area.. This door was unsecured and was able to be opened by the surveyor. This allowed for anyone entering the facility to have direct access to all areas of the facility without any supervision from staff. On 2/21/24 at 7:00 A.M., the surveyor entered the facility lobby and observed the door to the treatment area was propped open with a wet floor sign allowing access to the treatment area from the lobby. There was no staff present and no receptionist in the reception area. The surveyor was able to access areas of the facility through the unsecured door leading from the lobby area. On 2/22/24 at 7:00 A.M., the surveyor entered the facility and observed the door to the treatment area was propped open with a wet floor sign allowing access to the treatment area from the lobby. There was no staff present and no receptionist in the reception area. The surveyor was able to access areas of the facility through the unsecured door leading from the lobby area. During an interview on 2/22/24 at 7:45 A.M., the Facility Administrator (FA) said that the door leading to the treatment area from the lobby should never be left open. She said the expectation is that the door is always closed and secured. The FA said that she has already educated staff on making sure the door is closed at all times. The FA could not provide any documented evidence that education had been provided. The FA said that she was aware that the door leading to all areas of the facility was not secured and said she had informed the company that it needed to have a coded key pad on the door for safety. She said there is a work order in place to have a coded key pad applied to the door. Review of the documentation for the work order indicated that the work order was placed in September 2023 and that a second request was placed in February 2024. The work order did not have a date when work would be completed. During an interview on 2/22/24 at 10:15 A.M., the FA said that she does not have an estimated time the door will be fixed.”

“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: 44223 Based on record review, staff interview, and policy review, the facility failed to ensure staff conducted Pre-Dialysis Nursing Assessments with in one (1) hour of dialysis treatment for 4 of 10 applicable patients (#2, #3, #6, #7) records, out of a total sample of 12 patients. Findings Include: Review of the facility policy, titled Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, revised 10/2023, indicated the following but is not limited to: *Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge. *The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation. 1.) For Patient #2, the facility failed to conduct the Dialysis Nursing Assessment within the first hour of dialysis treatment per the facility policy. Patient #2 was admitted to the facility in 3/2023 with a diagnosis of End Stage Renal Disease requiring dialysis. Review of 9 treatment sheets, dated 1/29/24-2/16/24, indicated that for 4 of 9 treatments, the nursing assessment was not conducted within the first hour of treatment including the following: *On 1/31/24, the patient’s dialysis treatment began at 5:37 A.M., the nursing assessment was not completed until 7:47 A.M., exceeding the one (1) hour requirement. *On 2/5/24, the patient’s dialysis treatment began at 5:39 A.M., the nursing assessment was not completed until 9:21 A.M., exceeding the one (1) hour requirement. *On 2/9/24, the patient’s dialysis treatment began at 5:30 A.M., the nursing assessment was not completed until 7:27 A.M., exceeding the one (1) hour requirement. *On 2/12/24, the patient’s dialysis treatment began at 5:40 A.M., the nursing assessment was not completed until 7:51 A.M., exceeding the one (1) hour requirement. During an interview on 2/22/24 at 1:00 A.M., the Facility Administrator (FA) said the expectation is that the nurse completes the nursing assessment within the first hour of the patient being on dialysis treatment. 2.) For Patient #7, the facility failed to conduct the Dialysis Nursing Assessment within the first hour of dialysis treatment per the facility policy. Patient #7 was admitted to the facility in 1/2024 with a diagnosis of End Stage Renal Disease requiring dialysis. Review of 9 treatment sheets, dated 1/27/24-2/15/24, indicated that for 5 of 9 treatments, the nursing assessment was not conducted within the first hour of treatment including the following: *On 1/27/24, the patient’s dialysis treatment began at 11:06 A.M., the nursing assessment was not completed until 2:54 P.M., exceeding the one (1) hour requirement. *On 2/1/24, the patient’s dialysis treatment began at 10:47 A.M., the nursing assessment was not completed until 12:51 P.M., exceeding the one (1) hour requirement. *On 2/6/24, the patient’s dialysis treatment began at 10:30 A.M., the nursing assessment was not completed until 1:04 P.M., exceeding the one (1) hour requirement. *On 2/10/24, the patient’s dialysis treatment began at 10:57 A.M., the nursing assessment was not completed until 12:55 P.M., exceeding the one (1) hour requirement. *On 2/12/24, the patient’s dialysis treatment began at 6:08 A.M., the nursing assessment was not completed until 7:34 A.M., exceeding the one (1) hour, During an interview on 2/22/24 at 1:00 A.M., the Facility Administrator (FA) said the expectation is that the nurse completes the nursing assessment within the first hour of the patient being on dialysis treatment. 37349 3.) For Patient #3, the facility failed to conduct the Dialysis Nursing Assessment within the first hour of dialysis treatment per the facility policy. Patient #3 was admitted to the facility in 11/2023 with a diagnosis of End Stage Renal Disease requiring dialysis. Review of 9 treatment sheets, dated 1/29/24-2/16/24, indicated that for 4 of 9 treatments, the nursing assessment was not conducted within the first hour of treatment including the following: *On 2/5/24, the patient’s dialysis treatment began at 10:45 A.M., the nursing assessment was not completed until 4:39 P.M.., exceeding the one (1) hour requirement. *On 2/10/24, the patient’s dialysis treatment began at 6:09 A.M., the nursing assessment was not completed until 8:14 A.M.., exceeding the one (1) hour requirement. *On 2/12/24, the patient’s dialysis treatment began at 10:19 A.M., the nursing assessment was not completed until 12:12 P.M.., exceeding the one (1) hour requirement. *On 2/14/24, the patient’s dialysis treatment began at 10:24 A.M., the nursing assessment was not completed until 12:08 P.M.., exceeding the one (1) hour requirement. 4.) For Patient #6, the facility failed to conduct the Dialysis Nursing Assessment within the first hour of dialysis treatment per the facility policy. Patient #6 was admitted to the facility in 8/2016 with a diagnosis of End Stage Renal Disease requiring dialysis. Review of 9 treatment sheets, dated 1/29/24-2/16/24, indicated that for 5 of 9 treatments, the nursing assessment was not conducted within the first hour of treatment including the following: *On 1/31/24, the patient’s dialysis treatment began at 5:45 A.M., the nursing assessment was not completed until 7:19 A.M.., exceeding the one (1) hour requirement. *On 2/2/24, the patient’s dialysis treatment began at 6:04 A.M., the nursing assessment was not completed until 7:26 A.M.., exceeding the one (1) hour requirement. *On 2/5/24, the patient’s dialysis treatment began at 10:52 A.M., the nursing assessment was not completed until 1:13 P.M.., exceeding the one (1) hour requirement. *On 2/7/24, the patient’s dialysis treatment began at 10:00 A.M., the nursing assessment was not completed until 11:38 A.M.., exceeding the one (1) hour requirement. *On 2/12/24, the patient’s dialysis treatment began at 6:12 A.M., the nursing assessment was not completed until 7:52 A.M.., exceeding the one (1) hour requirement. During an interview on 2/22/24 at 1:00 P.M., the Facility Administrator (FA) said the expectation is that the nurse completes the nursing assessment within the first hour of the patient being on dialysis treatment.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 37700 Based on observation, record review, and interview, the facility failed to ensure the dialysis treatment order was delivered as prescribed relative to Blood Flow Rate (BFR-measured in milliliters per minute [ml/min]) in which the patient’s blood is pushed through the dialyzer during the process of dialysis for 1 of 8 applicable patient (#8), out of a total sample of 12 patients. Findings include: Patient #8 was admitted to the facility in October 2022 with a diagnosis of End Stage Renal Disease (ESRD), requiring dialysis. Review of the physician’s orders, dated, 9/26/23, indicated the BFR was to be delivered at a rate of 350. Review of 9 treatment records, dated 1/2/24 through 2/3/24, indicated the BFR was not delivered as prescribed for 4 out of 9 treatments, including the following: *1/2/24-the BFR was delivered at a rate of 275 for part of the treatment and a rate of 300 for part of the treatment, not the prescribed 350, with no documentation as to why the order was not followed. *1/27/24-the BFR was delivered at a rate of 280, not the prescribed 350, with no documentation as to why the order was not followed. *2/1/24 -the BFR was delivered at a rate of 200 for part of the treatment and a rate of 300 for part of the treatment, not the prescribed 350, with no documentation as to why the order was not followed. *2/3/24-the BFR was delivered at a rate of 300, not the prescribed 350, with no documentation as to why the order was not followed. During an interview on 2/22/24 at 7:35 A.M., the Facility Administrator, after reviewing the 4 treatment sheets, said that she could not find any documentation why the BFR was not delivered as prescribed during the identified treatments.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 44223 Based on review of the Facility Health Meeting (FHM) committee meeting minutes, incidence of infections, vaccinations, and staff interview, the facility failed to ensure monthly incidents of infections and hepatitis B vaccination rates were consistently measured, analyzed, and a plan was developed based on results of these monthly reports. Findings Include: Review of the facility policy, titled Continuous Quality Improvement Program, dated April 2021, indicated the following but is not limited to: PURPOSE: To improve patient safety and outcomes including the reduction of medical errors in accordance with the Quality Assessment and Performance Improvement (QAPI) requirements in the CMS Conditions for Coverage. *The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: Patient Safety, including - Review of sentinel events - Review of trends of adverse patient occurrences including falls and blood loss - Review of product, equipment, or medication notices or recalls - Infection Control, including - Incidence of infections - Vaccination rates for Hepatitis B, Influenza, and Pneumococcal - Adequacy of Dialysis (Kt/V) - Nutritional Status (Albumin) - Mineral Metabolism and Renal Bone Disease - Anemia Management - Vascular Access - Growth and Capacity - Mortality - review of deaths - Hospitalizations and Emergency Ambulance Transfers - Patient Satisfaction and Grievances, including KDQOL - Other indicators as reflected in the Facility Health Record application *Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. Review of the FHM minutes from 8/2023 through 1/2024 indicated that Infection Incident Logs and hepatitis B vaccination logs were not completed for 6 of the 6 months therefore not able to be tracked, trended, or analyzed within the FHM committee meeting. During an interview on 2/22/24 at 10:00 A.M., during the FHM review, the Facility Administrator (FA) said they do not track or have a list of monthly incidents of infections. She said that she is aware they have an issue with making sure hepatitis B vaccinations are offered and given but she has not been able to implement a plan because she has no Clinical Manager right now and staffing is challenged.”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. This Standard is not met as evidenced by: 44223 Based on review of the Facility Health Meeting (FHM) committee minutes, staff interview, and observation, the facility failed to prioritize an identified area needing improvement, ranking the area which has potential to affect patient health and safety as more urgent than those that do not have such potential in regard to the environment of the facility. Findings Include: Observations by the surveyor throughout recertification survey (2/20/24-2/22/24) included the following environmental areas of concern: - The access door to offices, staff areas, supply areas, and the treatment floor from the lobby was unsecured. This allows anyone to have direct access to these areas without any supervision from the facility staff. Review of the FHM documentation from 8/2023-1/2024 indicated that physical environment and safety was reviewed each month, but there was no effective action plan developed to address the unsecured door in the lobby. During an interview on 2/22/24 at 10:00 A.M., the Facility Administrator (FA) said that a work order had been created and filed to have a coded key pad installed on the door to enhance safety. She said that she has requested this twice. The FA said she had no time line on or when this issue would be resolved. Review of work order indicated that the original request to secure the door was initiated in 9/23. Further review indicated that a second request was done in 2/24. The work order did not indicate a resolution date.”

“PQ-NURSE MANAGER-12 MO RN+6 MO DIALYSIS CFR(s): 494.140(b)(1) (1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must- (i) Be a full time employee of the facility; (ii) Be a registered nurse; and (iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis. This Standard is not met as evidenced by: 44223 Based on staff interview and facility schedule review, the facility failed to ensure there is full time coverage of the Nurse Manager/Clinical Manager role during a leave of absence for the Dialysis Unit, as required. Findings Include: During the entrance conference with the Facility Administrator (FA) on 2/20/24, the FA informed the survey staff that the Clinical Manager (CM) was “out on maternity leave”. The FA explained there was not a nurse covering the CM position. She said there has been no CM since mid January and prior to that she had not had a CM from 6/23 through 9/23. She said the nurses working the floor have patient assignments of 3 patients and are responsible for medication administration and nursing assessments for all patients on the floor. The FA said there is no charge nurse designation. Review of the facility schedule, dated 2/20/24, indicated only one nurse was scheduled to work. Registered Nurse (RN) #5 was free floating(no assignment) and was responsible for medication administration, nursing assessments, and oversight of all patients on the treatment floor. There were 15 patients scheduled on the 1st shift, 13 patients scheduled on 2nd shift, and 12 patients scheduled on 3rd shift. There was no nurse assigned to cover the CM role. Review of the facility schedule, dated 2/21/24, indicated two nurses were scheduled to work. RN #1 and RN #4 both had assignments of 3 patients and each were responsible for medication administration and nursing assessments for half the floor. There were 20 patients scheduled on 1st shift, 20 patients scheduled for 2nd shift, and 12 patients scheduled for 3rd shift. There was no nurse assigned to cover the CM role. Review of the facility schedule, dated 2/22/24, indicated two nurses were scheduled to work. RN #1 and RN #2 both had assignments of 3 patients and each were responsible for medication administration and nursing assessments for half the floor. There were 19 patients scheduled for 1st shift, 21 patients scheduled for 2nd shift, and 12 patients scheduled for 3rd shift. There was no nurse assigned to cover the CM role. During an interview on 2/22/24 at 10:00 A.M., the FA said that the facility does not have a coverage plan for the CM. She said she believes the CM is going to be out for 6 months. The FA said so far her plan has been to try to ensure there are two nurses scheduled each day on the floor. She said she has been taking over the responsibilities of the CM in her absence. The FA said the nurses on the floor do not do any of the CM responsibilities. The FA is not a nurse and therefore is not able to take on the responsibilities of the CM. Further interview on 2/22/24 at 10:30 A.M. with the FA during the Facility Health Meeting review, she said that if there has to be a review or educate on nursing related issues she will pull the policy and review the policy with staff and try to get a nurse working on the floor to be available if staff have questions. The FA said they are doing the best they can but staffing is a challenge and she has difficulty getting a nurse to be free floating and not have an assignment.”

“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: 44223 Based on staff interview, medical record review, and policy review, the Medical Director failed to ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration to initiate treatment for 2 of 10 applicable patients (#2, #6) records, out of a total sample of 12 patients. Findings Include: Review of the facility policy, titled Anticoagulation, revised 10/23, indicated the following but is not limited to: *Purpose: To deliver anticoagulation therapy that: (1) reduces clotting within the extracorporeal circuit and prevents complications such as blood loss, (2) optimizes dialyzer efficiency and adequacy of dialysis, and (3) prevents bleeding secondary to over-anticoagulation during the hemodialysis treatment. *To anticoagulate the patient, the initial loading dose of heparin is administered through the venous fistula needle or venous port of the central venous catheter (CVC) at least three (3) to five (5) minutes prior to the initiation of the hemodialysis treatment. 1.) For Patient #2, the Medical Director failed to ensure that staff adhered to the heparin administration policy and waited the 3-5 minutes after administration to initiate dialysis treatment. Review of the medical record indicated Patient #2 had a physician order to administer a loading dose of heparin 2000 units every dialysis treatment. Review of 9 treatment sheets, dated 1/29/24-2/16/24, indicated that for 5 of 9 treatments, staff failed to wait 3-5 minutes after administration of heparin to initiate treatment, including the following: *1/31/24-Treatment began at 5:37 A.M., a loading dose of heparin 2000 units was documented as given at 5:38 A.M., not the 3-5 minutes prior to start of treatment per facility policy. *2/2/24-Treatment began at 5:30 A.M., a loading dose of heparin 2000 units was documented as given 5:38 A.M., not the 3-5 minutes prior to start of treatment per facility policy. *2/5/24-Treatment began at 5:39 A.M., a loading dose of heparin 2000 units was documented as given at 5:44 A.M., not the 3-5 minutes prior to start of treatment per facility policy. *2/7/24-Treatment began at 5:42 A.M., a loading dose of heparin 2000 units was documented as given at 5:44 A.M., not the 3-5 minutes prior to start of treatment per facility policy. *2/9/24-Treatment began at 5:30 A.M., a loading dose of heparin 2000 units was documented as given 5:44 A.M., not the 3-5 minutes prior to start of treatment per facility policy. During an interview on 2/22/24 at 10:00 A.M., the Facility Administrator (FA) said that staff should be waiting the 3-5 minutes after the initiation of heparin before they start treatment. 37349 2.) For Patient #6, the Medical Director failed to ensure that staff adhered to the heparin administration policy and waited the 3-5 minutes after administration to initiate dialysis treatment. Review of the medical record indicated Patient #6 had a physician order, dated 9/18/22, to administer a heparin loading dose of 2000 units every dialysis treatment. Review of 9 treatment sheets, dated 1/29/24 through 2/16/24, indicated that for 5 of 9 treatments, staff failed to wait 3-5 minutes after administration of heparin to initiate treatment, including the following: *1/31/24-Treatment began at 5:45 A.M., a loading dose of heparin 2000 units was documented as given at 6:15 A.M., not the 3-5 minutes prior to the start of treatment per the facility policy. *2/5/24-Treatment began at 10:52 A.M., a loading dose of heparin 2000 units was documented as given at 10:52 A.M., not the 3-5 minutes prior to the start of treatment per the facility policy. *2/7/24-Treatment began at 10:00 A.M., a loading dose of heparin 2000 units was documented as given at 10:03 A.M., not the 3-5 minutes prior to the start of treatment per the facility policy. *2/9/24-Treatment began at 8:53 A.M., a loading dose of heparin 2000 units was documented as given at 8:53 A.M., not the 3-5 minutes prior to the start of treatment per the facility policy. *2/12/24-Treatment began at 6:10 A.M., a loading dose of heparin 2000 units was documented as given at 6:12 A.M., not the 3-5 minutes prior to the start of treatment per the facility policy. During an interview on 2/22/24 at 10:00 A.M., the Facility Administrator (FA) said that staff should be waiting the 3-5 minutes after the initiation of heparin before they start treatment.”