Davita Pearland Dialysis

“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: 28297 Based on observation, interview, and policy review, the facility failed to ensure staff removed all non-disposable items from the dialysis station between patient treatments for two of three survey days. The failure to removed and clean non-disposable items from the dialysis station between patient treatments had the potential for contamination of the non-disposable items that would potentially be used on different patients that could affect 85 in-center patients. Findings include: Observation on 03/04/24 at 1:55 PM revealed Patient Care Technician (PCT) 2 cleaning the station at Station 5. The PCT never removed the hemostats from the machine then proceeded to set up the station for the next patient. Observation on 03/05/24 at10:05 AM revealed PCT 6 cleaned the dialysis station at Station 19. PCT6 never removed the hemostats from the station. During an interview on 03/05/24 at 10:15 AM PCT6 stated he/she had forgotten to remove them during the disinfection process however he/she should have removed them. During an interview on 03/06/24 at 1:15 PM the Clinic Coordinator confirmed the hemostats should be removed and disinfected between patient treatments to ensure staff are not using the same equipment for different patients that could be contaminated. Review of the facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023 indicated, “ ....At the end of each treatment, the dialysis station will be cleaned and disinfected ...Non-disposable items are to be disinfected after each patient use ...Hemostats(blood line clamps)should be in the open position and fully submerged in an appropriate disinfection solutions ...””

“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: 28297 Based on observation, interview, and policy review, the facility failed to ensure a patient wore a mask that was covering his/her nose during the initiation of dialysis via a Central Venous Catheter (CVC-thin, flexible tube is inserted into a vein, usually below the collarbone. It is guided (threaded) into a large vein above the right side of the heart) and during CVC dressing changes for one of two observations. The failure to ensure the mask was covering the nose as required in policy, had the potential for contamination of the CVC and had the potential for increased the risk of infections, and could affect 25 of 85 in-patients that have CVCs in the facility. Findings include: During an observation on 03/05/24 at 10:20 AM Registered Nurse (RN) 9 was at Station 10 discontinuing the treatment via a CVC for Patient (P) 14. RN9 completed CVC initiation of the dialysis treatment and the CVC dressing change, however the patient’s mask remained below his/her nose the entire time. During an interview on 03/05/24/24 at 10:35 AM RN9 confirmed the patient’s mask was not covering his/her nose as required to prevent contamination. During an interview on 03/06/24 at 1:15 PM the Clinic Coordinator confirmed it was part of the facility policy for the patient to wear a mask covering the mouth and nose during initiation of dialysis via a CVC and CVC dressing change to prevent contamination of the CVC. Review of the facility’s policy titled, “Central Venous Catheter (CVC) with Clearguard HD [Hemodialysis] antimicrobial End Cap Procedure,” revised October, indicated, “Put on Personal Protective Equipment (PPE) and provide a mask to the patient. Teammate and patient will wear masks covering the nose and mouth during the procedure. These measures are vital to preventing the exposure of the catheter and exit site to nasal droplets and infectious bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) ...””

“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: 28297 Based on observation, interview, and policy review, the facility failed to ensure two of two staff dumped the normal saline prime (the fluid recirculation in the dialyzer and lines from the time the machine is set up for the patient and treatment initiation) per policy for two of two observations. The failure to dump for prime per policy had the potential for adverse event and could affect 85 in-center patients. Findings include: 1. Observation on 03/05/24 at 10:15 AM revealed Registered Nurse (RN)2 initiated the treatment for Patient (P)14 at Station 10. RN2 did not dump the prime of normal saline prior to starting the patient’s dialysis treatment. During an interview on 03/05/24 at 10:35 AM, RN 2 stated he/she did not think it was required to dump the normal saline prime. 2. During an observation on 03/05/24 at 10:55 AM, RN10 initiated the treatment for P12 at Station 17. RN10 did not dump the prime prior to initiation of the dialysis treatment. During an interview on 03/05/24 at 2:30 PM, RN10 stated they do not dump the prime at the initiation of dialysis. During an interview on 03/06/24 at 1:15 PM the Clinic Coordinator confirmed that it was required to dump the normal saline prime prior to initiation of dialysis to ensure the patient is getting fresh normal saline and not normal saline that had been recirculating for a period of time. Review of the facility policy titled, “Treatment initiation Utilizing Fresenius 2008 Series Dialysis Delivery Systems with All Single Use Dialyzer Types and Streamline or Combiset or Nipro Blood Lines,” revised October 2021 indicated, “ ...Clamp arterial and venous blood lines ....Open the clamp on the arterial line and flush for 25 seconds (approximately 50 ml of saline) through the arterial line. Clamp the arterial blood line ...Volume length of saline line to patient end of the arterial line is between 30 and 40 ml, depending on the blood line used ...Unclamp venous line, turn blood pump on and flush 250 ml of normal saline into priming container (which takes 38 seconds at a pump speed of 400ml/min ...This flushes the dialyzer and blood lines with fresh saline prior to treatment initiation ...””

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 30124 Based on observation, interview and record review the facility failed to ensure a sanitary environment was maintained for the safety of patients in that: 1. Patient treatment areas were properly cleaned and disinfected between patient use including the removal of sticky tape residue on treatment chairs and side tables. 2. Portable computer stands were observed with visible dust on the lateral surface areas. 3. Open medications were not labeled when opened to determine an expiration date per manufacturer’s recommendations. Policies Reviewed: Review on 10/03/2023 of the facility’s current policy titled: “Infection Control for Dialysis Facilities”; policy: 1-05-01; Revision Date April 2023. Purpose: To minimize the spread of infections or blood borne pathogens in the dialysis environment. DISINFECTION 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system. Pressurized washers, spray bottles, or sprayers for cleaning purposes will not be used on wall boxes or the adjoining area Teammates will monitor and address wall box residue/build up and patency issues. ii. Priming containers are to be emptied prior to disinfection. Drain line and water supply line should not be placed with ends in prime containers or in a position where they can drip into or contaminate the prime bucket. Review on 11/14//2023 of the facility’s current policy titled: “Medication Policy”; policy : 1-06-01; Revision date: October 2023. Purpose: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. Policy: 1. The Facility Administrator/designee is responsible for supervising the handling, storing, disposing, administering, and controlling of medications and performs a monthly audit and inventory. 13. All open or unopened medication packages (i.e. vials, ampules etc.) are stored according to the manufacturer’s directions. Do not use any medication that has been stored improperly or has expired. Disinfection/Cleaning On the morning of 11/15/2023 surveyor along with Staff ID #B observed the cleaning/disinfection of patient treatment stations 5 through12 in between patient shifts by the patient care technician staff. Staff confirmed the patient treatment stations were cleaned and ready for use. Surveyor along with Staff ID #B observed the above stations had sticky tape residue remaining on the treatment chairs and side tables. The rolling computer carts ten of ten were also observed to have visible dust and debris on the lateral surfaces of the cart. Staff ID #B confirmed the above had not been properly cleaned and tape should not be placed directly on the patient’s chairs or tables. Medication Review on 11/14/2023 of the manufactory’s recommendations for use for ExCept Plus Liquid Antimicrobial Exit Site, Skin & wound cleaner states the product is “stable for up to 6 months after opening”. Observation of the patient treatment area on 11/14/2023 at 10:45 AM along with the Clinical Services Manager, Staff ID #B the surveyor observed one open bottle of ExCept Plus Liquid Antimicrobial Exit Site, Sin & wound cleaner that was not labeled with an open date or expiration date. Interview with Staff ID #B confirmed the open bottle of ExCept had not been labeled and a six-month expiration date could not be determined.”

“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: 30124 Based on observation, interview and record review, the facility’s direct care staff failed to follow manufacturer’s recommendation for use changing filters of oxygen concentrators in use by patients in the facility in 4 of 4 oxygen concentrators in use in the facility. Findings: Review of the Manufacture’s Direction for use of the DeVilbiss 5-Liter Oxygen Concentrator Service Manual, series 525DS, dated LT- 2013 revealed the following manufacture’s direction for use. “In case of a change of patient, the device must be reconditioned to protect the user. Reconditioning must only be carried out by the manufacturer or service provider. DeVilbiss Healthcare recommends the following as minimum between-patient maintenance. If the unit is due for periodic provider maintenance, those items should be completed in addition to the list below. 1. Discard oxygen tubing, cannula/mask, oxygen outlet connector, and humidifier bottle. 2. Replace cabinet air filter. 3. Clean the concentrator cabinet. 4. Inspect all plugs, cords, and components. Replace any damaged or worn components. 5. Check oxygen concentration. If the unit falls within specification, the extended life intake bacteria filter does not need to be replaced between patients. If the concentration is not within specification, refer to troubleshooting.” Provider’s Note - Cleaning and Disinfection When There is a Patient Change. 10. Replace the cabinet air filter on the back of the device if applicable. 11. Check the oxygen concentration. If the device is within specification, the extended life intake bacterial filter does not need to be replaced between patients. Review of the facility’s current policy and procedure on Use of Oxygen Concentrators; Policy # 1-02-04, revised October 2023 directs staff as follows: “ Follow Manufacturer Instructions for Use regarding any additional cleaning maintenance.” Observations on 11/14/2023 of patient #3 revealed DeVilbiss oxygen concentrators model # 525DS, serial # F654060, machine #2 in use at 2 liters a minute via nasal canulae. Concentrator had a filter on the back of the concentrators and exposed. Observation on 11/14/2023 of the storage area near the nursing station revealed 5 DeVilbiss oxygen concentrators. Model numbers 525DS. Equip# Serial # Model # Manufacture Date 1 F657966DS 525DS 2011 filter on back of concentrator 2 F654060DS 525DS 2011 filter on back of concentrator 4 N083045DS 525DS 2017 filter on back of concentrator 6 B211251011DS 525DS 2021 new back door, no cabinet door filter 8 B216020533DS 525DS 2022 filter on back of concentrator The Surveyor requested documentation that the oxygen concentrators were maintained by the facility based on manufacture’s recommendation. Interview on 11/15/2023 with the Facility’s Bio-medical staff revealed documentation of a weekly clean log for oxygen concentrators #’s 1, 2, 4, & 8. No documentation was presented that the cabinet air filters had been changed by the staff between patient use. Interview on 11/15/23 at 14:05 PM with the facility’s clinical services manager confirmed the oxygen concentrators were cleaned and disinfected by the staff between patients and the cabinet air filters were not being changed by the staff between patients. Interview on 11/15/2023 14:30 PM with the Facility’s Chief Biomedical Technician revealed the nursing staff is responsible for cleaning and changing the filters of the oxygen concentrators but there was no evidence that the staff changed the filters between patients.”