Continental Dialysis Care

“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: 29151 Based on observation, policy review and staff interview, the facility failed to ensure staff utilized proper hand hygiene, along with glove changes, during initiation and termination of treatment. The failure affected 4 of 6 observations of care. According to the CDC, hand washing is the most important measure to prevent contaminant transmission. The findings included: Observation of discontinuation of treatment conducted on 04/08/24 at 11:45 AM revealed Staff B, a Patient Care Technician, at Station #3. Staff B donned clean gloves, touched the computer screen, and disconnect the blood lines. Staff B removed her gloves, proceeded to the clean supply cart, donned clean gloves, and continue to remove the patient’s access needles. Staff B failed to perform hand hygiene after gloves changes and prior to removing the access needles. Observation of discontinuation of treatment conducted on 04/08/24 at 12:15 PM revealed Staff B, a Patient Care Technician, at Station #2. Staff B donned clean gloves, touched the computer screen, then proceeded to disconnect the blood lines. Staff B removed her gloves, proceeded to the clean supply cart, donned clean gloves, grabbed a clean glove for the patient and continue to remove the patient’s access needles. Staff B failed to perform hand hygiene after gloves changes and prior to removing the access needles. Observation of initiation of treatment conducted on 04/08/24 at 12:25 PM revealed Staff B, a Patient Care Technician, at Station #4. Staff B donned clean gloves, placed a barrier underneath the catheter site, removed the dressing to the access site and the limbs. Then removed gloves, donned clean gloves and proceeded to clean the access site with a disinfectant solution and gauze. Staff B failed to perform hand hygiene after removing the dirty dressing and prior to cleansing the site. Observation of discontinuation of treatment conducted on 04/08/24 at 12:50 PM revealed Staff B, a Patient Care Technician, at Station #1. Staff B donned clean gloves, disconnected the blood lines, proceeded to another station to talk to the nurse, then went to Station #2 and disposed of the blood lines. Staff B removed her gloves, donned clean gloves and proceeded to disinfect Station #2. Interview with Staff B on 04/10/24 at 12:15 PM confirmed the staff failed to perform hand hygiene multiple times. Facility policy titled Infection Control” last revised 11/29/22, documents “Hands are always washed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretion and contaminated items””

“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: 22517 Based on observation, interview and policy review revealed that the facility failed to adhere to established standards of practice regarding cleaning and disinfection of contaminated surfaces, medical devices and equipment. This is evidenced by the staff brought items to the dialysis machine, used these items and then placed the used item in a clean area prior to cleaning the item; the staff failed to completely open all sides of the dialysis chair when cleaning and the staff failed to ensure the dialysis machine is not cleaned while the patient is still holding their dialysis access. Failures in environmental cleaning and disinfection have led to transmission of bloodborne pathogens and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces) must be performed between patient uses to prevent transmission of dangerous pathogens. The findings included: Review of the facility’s policy regarding Cleaning & Disinfection of Equipment, Supplies and Treatment Area, Last Revision Date 11/15/2023, documented “All routinely touched reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. Caregivers will ensure that cracks/crevices come in contact with the bleach solution. This includes, but is not limited to the: dialysis machine chair, including the top and bottom of the chair-side table (s) bedside table television, phone counters and wall boxes Dialysis chairs will be reclined, and all areas inspected and disinfected where blood could accumulate and not be readily noticed.” 1) An observation of Staff D, Patient Care Technician, at Station 26 was conducted on 04/08/24 beginning at 1:03 PM, the staff began cleaning the dialysis machine at Station #26, however, the patient who had previously received dialysis treatment, remained at the station holding her access site. 2) Observations conducted on the B side treatment floor on 04/08/24 beginning at 11:30 AM revealed that the staff failed follow the standards of practice regarding cleaning and disinfecting the dialysis chairs and equipment brought to the dialysis station as follows: a. Observation of the dialysis machine set up at Station 24 was conducted on 04/08/24 at 12:25 PM with the Patient Care Technician, Staff D. Staff D took the Myron Meter to the dialysis station and obtained a dialysate sample. After performing the conductivity test, Staff D took the Myron Meter to the counter and rinsed the meter with RO (Reverse Osmosis) water. However the staff did not clean the Myron meter after taking the meter to the dialysis station. An interview was conducted on 04/10/24 beginning at 04/10/24 at 11:50 AM with Staff D. The above observations were reviewed with the staff and she confirmed she did not clean the Myron Meter after using the meter at the dialysis station and she cleaned the dialysis machine while the previous patient remained at the station holding her access site. She further confirmed she did not open the sides of the dialysis chair when cleaning the chairs. b. Observation of the Patient Care Technician, Staff E, at Station 19 at approximately 12:08 PM revealed that the staff was cleaning the dialysis chair at the station. The staff did not open sides of the dialysis chair when she cleaned the dialysis chair. Later an observation of dialysis machine set up at Station 19 at approximately 12:20 PM with Staff E. Staff E took the Myron Meter to the dialysis station and obtained a dialysate sample from the dialysis machine and poured it into the Myron Meter and read the results. After performing the conductivity test, Staff E did not clean the Myron Meter after using it before storing it on the counter. An interview was conducted on 04/10/24 beginning at 12:10 PM with Staff E. The above observation was reviewed with the staff and she confirmed she did not clean the meter and did not open the sides of the dialysis chair. c. Observation of cleaning the dialysis chair at Station 23 was conducted on 04/08/24 at approximately 12:27 PM with Staff I, Patient Care Technician. The staff wiped the center of the dialysis chair and the tables on the chair. However, the staff did not open the sides of the chair. The staff was also observed setting up the dialysis machine at approximately 12:58 PM. The staff took the Myron Meter to the dialysis station and obtained a dialysate sample from the dialysis machine. After completing the conductivity test, the staff took the Myron Meter and stored it on the counter. The staff did not clean the Myron Meter after using it at the dialysis station and storing the meter on the counter. It should be noted that the Patient Care Technicians, Staff D, E and I, used the Myron Meter at multiple stations and did not clean the Myron Meter between usage during the observation from 11:30 AM to 1:08 PM. An interview was conducted on 04/10/24 at approximately 12:00 PM with Staff I, she confirmed she did not open the sides of the dialysis chair when cleaning and did not clean the Myron Meter after taking it to the dialysis station.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 22517 Based on administrative record review and staff interview, the facility failed to monitor and implement the established infection control policies. The facility’s failed to ensure staff had current tuberculosis monitoring. This is evidenced by 7 of 8 staff reviewed did not have evidence of current annual Tuberculosis evaluation. The findings included: Review of the facility’s policy regarding Associate Health Program, last revised 11/01/2022, documented that Associates will be screened for tuberculosis on hire and at least annually thereafter as outlined in this policy. Annual testing A TB Risk Assessment Questionnaire - Associates will be done on associates on an annual basis in each center as outline in the TB-Associates Screening Protocol 1) Review of the personnel file for Staff H, Social Worker, hire date of 06/11/2013, revealed that the staff’s personnel file did not provide evidence of a current questionnaire or monitoring of the staff’s tuberculosis status. The latest documented tuberculosis screening in the staff’s personnel’s file is dated January 2018. 2) Review of the personnel file for Staff G, Social Worker, hire date of 09/30/2013, revealed that the staff’s personnel file did not provide evidence of a current questionnaire or monitoring of the staff’s tuberculosis status. The latest documented tuberculosis screening in the staff’s personnel’s file is dated December 9, 2019. 3) Review of the personnel file for Staff F, Registered Dietitian, hire date of 02/22/2021, revealed that the staff’s personnel file did not provide evidence of a current questionnaire or monitoring of the staff’s tuberculosis status. 4) Review of the personnel file for Staff E, Patient Care Technician, hire date of 09/01/2013, revealed that the staff’s personnel file did not provide evidence of a current questionnaire or monitoring of the staff’s tuberculosis status. The latest documented tuberculosis screening in the staff’s personnel’s file was not dated. 5) Review of the personnel file for Staff D, Patient Care Technician, hire date of 09/01/2013, revealed that the staff’s personnel file did not provide evidence of a current questionnaire or monitoring of the staff’s tuberculosis status. The latest documented tuberculosis screening in the staff’s personnel’s file is dated 01/25/23. 6) Review of the personnel file for Staff C, Registered Nurse, hire date of 07/23/2018, revealed that the staff’s personnel file did not provide evidence of a current questionnaire or monitoring of the staff’s tuberculosis status. The latest documented tuberculosis screening in the staff’s personnel’s file is dated 08/15/22. An interview was conducted on 04/10/24 at approximately 2:00 PM with the Administrator who reported that he had not done the tuberculosis screening on his employees for 2024. He further confirmed that the above staff did not have a current TB questionnaire completed.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 29151 Based on observation, policy review and staff interview, the facility failed to ensure all supplies were maintained and operated in accordance with the manufacturer’s recommendations, as evidenced by the failure of the staff to ensure supplies readily available for use were labeled with open date and within expiration dates and failure to perform conductivity testing according to policies and procedures. The findings included: 1) Observation conducted in the treatment floor on 04/08/24 at 11 AM revealed a storage cart with the Myron meter and multiple solutions. The following supplies were on the cart: A bottle of Mesa Lab Conductivity solution 14/MS with instructions to discard 30 days after opening. The bottle approximately a quarter filled with solution, was not dated with opening date. Mesa Lab 7 Ph solution with instructions to discard 90 days after opening, was a quarter filled with solution and no open date. Conductivity standard 50 MS/CM solution with instructions to discard 30 days after opening was dated 03/05/24. Interview with Staff A, a Patient Care Technician, verified the solutions were not dated and one was expired and she further explained that the person who opens typically checks the solutions and expiration dates. 22517 2) Review of the facility procedure PRO-1-27 Myron L D-6 Meter, Initial Date 10/08/2020, usage documented to “measure conductivity: l. Rinse cell cup 3 times with sample to be measured. (This conditions the temperature compensation network and prepares the cell.) 2. Refill cell with sample 3. press (cond) 4. Take reading” Multiple observations on the B treatment side on 04/08/24 beginning at 11:30 AM revealed that the staff failed to perform the conductivity test by the Myron Meter appropriately as follows: a. Observation of the dialysis machine set up at Station 24 was conducted on 04/08/24 at 12:25 PM with the Patient Care Technician, Staff D. Staff D took the Myron Meter to the dialysis station and obtained a dialysate sample in a 30 cc cup and poured the sample into the Myron Meter and read the results. The staff did not rinse the cell cup on the Myron Meter three times before measuring the sample. An interview was conducted on 04/10/24 beginning at 04/10/24 at 11:50 AM with Staff D. The above observation was reviewed with the staff and she confirmed she did not perform the correct procedure when performing the conductivity test. b. Observation of dialysis machine set up at Station 19 was conducted on 04/08/24 at approximately 12:20 PM with the Patient Care Technician, Staff E. Staff E took the Myron Meter to the dialysis Machine and obtained a sample from the dialysis machine and poured it into the Myron Meter and read the results. The staff did not rinse the cell cup on the Myron Meter three times before measuring the sample. An interview was conducted on 04/10/24 beginning at 12:10 PM with Staff E. The above observation was reviewed with the staff and she confirmed she did not perform the correct procedure when performing the conductivity test. c. Observation of dialysis machine set up at Station 23 was conducted on 04/08/24 at approximately 12:58 PM with Staff I, Patient Care Technician. The staff took the Myron Meter to the dialysis station and obtained a dialysate sample from the dialysis machine and poured the dialysate sample into the Myron Meter. The staff did not rinse the cell cup on the Myron Meter three times before measuring the sample. An interview was conducted on 04/10/24 at approximately 12:00 PM with Staff I, she confirmed she did not perform the correct procedure when performing the conductivity test.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 22517 Based on clinical and administrative record review and staff interview, the facility failed to provide the necessary care and services to manage the patient’s volume status for 2 of 3 sampled home patients (Patient # 8 and # 10). This is evidenced by the failure of the Home Hemodialysis and Home Peritoneal dialysis patients failed to consistently monitor their blood pressure and weight during treatment. The findings included: 1) Review of the clinical record for Patient # 8 revealed that the physician prescribed for the patient to perform hemodialysis at home with NxStage five days a week. Review of the 13 treatment sheets from 03/17/24 to 04/06/24 revealed that on 9 of 13 treatments the patient failed to consistently document her blood pressure during treatment and/or pre and/or post treatment vital signs. The patient also did not consistently record her weight. 04/06/24 - no blood pressure recorded during the treatment 04/05/24 - no blood pressure recorded during the treatment 04/04/24 - no blood pressure recorded during the treatment 03/31/24 - no blood pressure recorded during the treatment 03/29/24 - no blood pressure recorded during the treatment 03/28/24 - no blood pressure recorded during the treatment 03/23/24 - no blood pressure recorded during the treatment and no post vitals 03/19/24 - no blood pressure recorded during the treatment and there are no pre and post vital signs or weights 03/17/24 - no blood pressure recorded during the treatment and there are no pre and post vital signs or weights Further review of treatments sheets for February and March revealed the same inconsistent pattern of the patient failing to take her blood pressure throughout her treatment or performing pre and post vital signs and weights. An interview was conducted on 04/10/24 in the afternoon with the Home Training Nurse. The above irregularities were reviewed with the nurse who confirmed the patient’s inconsistent behavior of performing treatments and monitoring during treatment. 2) Review of the clinical record for Patient # 10 revealed that the physician prescribed for the patient to receive peritoneal dialysis at home. Review of the home treatment records for March revealed that the patient was not recording her blood pressure and weights post treatments. An interview was conducted on 04/10/24 in the afternoon with the Home Training Nurse. The above irregularities were reviewed with the nurse confirmed the patient’s failure to document performing her taking her blood pressure and/or weights post 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: 29151 Based on record review, policy review and interview, it was determined, the clinical staff failed to ensure dialysis prescriptions were followed for 3 of 10 sampled patients. The failure included deviation of the prescribed Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR) for Patient #1; failure to follow Heparin orders for Patient #8 and failure to document the Dialysate for Patient #10. The findings included: 1) Clinical record review conducted on 04/09/24 revealed Patient #1 has physicians’ orders for dialysis treatment as of 03/08/23 for Blood Flow Rate (BFR) of 350 and Dialysate Blood Flow Rate (DFR) of 800. Review of the treatment records indicate the following: Treatment record dated 04/08/24 indicates the staff did not follow the prescribed BFR. Treatment record dated 04/05/24 indicates the staff did not follow the prescribed BFR. Treatment record dated 04/01/24 indicates the staff did not follow the prescribed BFR and DFR. Treatment record dated 03/29/24 indicates the staff did not follow the prescribed BFR and DFR. Treatment record dated 03/20/24 indicates the staff did not follow the prescribed BFR and DFR. Treatment record dated 03/11/24 indicates the staff did not follow the prescribed BFR and DFR. Treatment record dated 03/08/24 indicates the staff did not follow the prescribed BFR and DFR. Interview with the Clinic Manager on 04/10/24 at 11:55 AM verified the staff did not follow the prescription and did not document the rationale for the changes. Facility policy titled “Monitoring and Documentation Of Patient Care During Treatment” last revised 11/29/22 documents “If a patient prescription was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation).” 22517 2) Review of the clinical record for Patient # 8 revealed that the physician prescribed for the patient to perform hemodialysis at home with NxStage five days a week. The physician orders documented a Heparin order of 3000 units twice a month. Review of the treatment sheets from 03/02/24 to 04/06/24, revealed that the patient documented administering Heparin 3000 units every treatment for 11 treatments from 04/06/24 through 03/21/24. 03/19/24 and 03/17/24 - no heparin documented 03/13/24 - heparin 3000 units documented 03/12/24, 03/10/24 - no heparin documented 03/09/24 - Heparin 3000 units documented 03/06/24, 03/05/24, 03/04/24, 03/03/24, and 03/02/24 - no heparin documented Further review of the 16 treatments for February revealed that the patient documented she administered Heparin 3000 units on 7 treatments as follows. The other 9 treatments, the patient did not document the administration of Heparin. 02/18/24, 02/16/24, 02/13/24, 02/09/24, 02/06/24, 02/02/24 and 02/01/24 An interview was conducted with the Home Training Nurse (HTN) on 04/10/24 in the afternoon. The surveyor questioned the HTN regarding the Heparin Order. She stated that the patient is supposed to administer the Heparin 3000 units every treatment. The surveyor explained that the orders document Heparin 3000 units twice a month. Additionally the patient is not performing the daily Heparin dosing and the documented physician order has the administration as twice monthly. The patient is not performing that as well and this has been occurring for several months. 3) Review of the clinical record for Patient # 10 revealed that the physician prescribed for the patient to receive Peritoneal dialysis at home and prescribed for the patient to utilize dialysate of dextrose 2.5, 1.5, or 4.5 %. However review of the home treatment records for March did not document a solution used during the treatment. An interview was conducted on 04/10/24 in the afternoon with the HTN, who stated that the Amia cannot note the different solution which was used during treatment. The patient would have to document separately. She further stated that the patient has her own records but the HTN did not inform the patient to submit for her to review.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 22517 Based on observation, administrative record review and staff interview, the facility failed to ensure that the clinical staff performed to appropriate access care. This is evidenced by a random observation of the initiation of treatment, the clinical staff failed to utilize aseptic technique to minimize risk of infection while performing access care. The findings include: Review of the facility policy regarding AVF-AVG Cannulation, Treatment Initiation and Termination, Last Revision Date 11/15/23, documented “The access will be washed with antibacterial soap and water or antiseptic wipe, prior to preparing the site for cannulation. The access is palpitated for thrill and auscultated for bruit. Access is assessed for signs of infection, open sores, edema, and any potential problems for needle cannulation. A clean underpad is placed under the access extremity. The first needle insertion needle site is identified and the area cleaned using Aseptic Non-Touch Technique (ANTT) with an approved antiseptic product per manufacturer’s instructions. The second needle insertion site is prepared as just described. Each needle insertion site is then disinfected according to manufacturer’s instructions with one of the following products: 2% Chlorhexidine with alcohol > 70 % Alcohol > 10% Povidone-iodine Allow disinfectant to air dry. The site is never ‘fanned’ or ‘blown on’ to speed drying as this contaminates the area that was just disinfected. If the access is touched after being disinfected, it must be disinfected again before needle insertion.” 1) An observation of the initiation of care for the patient at Station # 23 was conducted on 04/08/24 at 11:58 AM with Patient Care Technician, Staff I, revealed that the patient was wheeled into the treatment floor and taken to the dialysis station. The patient was noted to have a clear “saran” wrap wrapped around her right upper arm. Staff I donned clean gloves, removed the saran wrap and wiped the access site with alcohol pad then proceeded to palpate over the site she had just wiped with the alcohol pad. She then inserted the first needle. The staff did not clean the access site again after palpating the site nor was the access washed prior to preparing the site for cannulation. Then the PCT performed the same procedure on the second access site of cleansing, palpating, and inserting the needle. Staff I again failed to cleanse the area after palpating the insertion site. An interview was conducted on 04/10/24 beginning at 12:00 PM with Staff I. The above observation was reviewed with the staff, who confirmed the above observation and staff failure.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 22517 Based on staff interview, administrative and clinical record review, the facility failed to ensure that the home training nurses accurately reviewed home records to identify irregularities for 3 of 3 sampled Home Therapy Patients, 2 of 2 Home Hemodialysis and 1 of 1 Peritoneal Dialysis Patients (Patient # 8, # 9 and # 10). This is evidenced by the staff failure to identify that the Peritoneal Dialysis had identified issues with documenting the dialysate , documenting the post treatment blood pressure and weights for several months; failed to identify concerns when the Home Hemodialysis patient did not perform , every 30 minute monitoring and blood pressure monitoring at the initiation of treatment, post treatment and documenting of weights pre and post treatment. Such review assists staff in monitoring the home patients’ status by determining if patients are following their treatment plans and/or having problems with their dialysis at home. The findings included: 1) The Home Training Nurses failed to identify irregularities with the home record review when home patients failed to perform the appropriate monitoring; home patients failed to consistently monitor their blood pressure pre, post and during treatment as appropriate; failed to ensure the patient was performing and/or documenting weights as appropriate as follows: a. The Home Training Nurse failed to provide the necessary care and services to manage the patient’s volume status for 2 of 3 sampled home patients (Patient # 8 and # 10). This is evidenced by the failure of the Home Hemodialysis and Home Peritoneal dialysis patients failed to consistently monitor their blood pressure and weight during treatment. The Home training nurse reviewed the patients home records but did not identify irregularities with the patients documentation of blood pressure and weights. Please see V 543 for additional details. b. The Home Training Nurse failure to ensure home orders were accurate and failed to identify irregularities with the patient following the Heparin orders for Patient #8 and failed to identify irregularities with the patient documenting the Dialysate used in her treatment for Patient #10. Please see V 544 for additional details. An interview was conducted on 04/10/24 in the afternoon with the Home Training Nurse who confirmed she did not identify the above irregularities associated with the Home Hemodialysis and Home Peritoneal Dialysis Patients.”