Davita Lock City 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: 34528 Based on policy review, observation, and interview, staff did not follow standard infection control practices regarding the use of gloves and hand hygiene. Patients were not offered to perform hand hygiene post treatment, after holding their needle sites for two of two hemodialysis patients (Patient #8 and #13). Findings include: Review of the policy “Infection Control for Dialysis Facilities,” last revised April 2024, indicated all teammates will perform hand hygiene prior to gloving and immediately after removal of gloves, after contamination with blood or other infectious material, after patient and dialysis delivery system contact, between patients even if the contact is casual, and before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station. Gloves will be changed when soiled with blood, dialysate, or other body fluids; when going from a “dirty” area or task to a “clean” area or task; when moving from a contaminated body site to a clean body site of the same patient; and after touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system. Review of the policy “Central Venous Catheter (CVC) with Clear guard HD Antimicrobial End Caps Procedure,” last revised October 2023, indicated teammates are to perform hand hygiene per procedure, put on personal protective equipment (gloves, mask, gown, and/or face shield), and provide a mask to patient. The teammate and patient will wear masks covering the nose and mouth during this procedure. If the teammate performing this procedure assisted the patient to put on their face mask, re-perform hand hygiene per procedure and put on clean gloves. Remove old dressing and discard. Remove gloves and discard. Perform hand hygiene per procedure and re-glove. Observation on 08/21/24 at 12:15 PM at Station #2 for Patient #10 revealed they had a left arm fistula (surgically created access for dialysis) and right side central venous catheter (tube inserted into a large vein in the body to provide access for dialysis). Staff (F), Registered Nurse, cannulated the fistula then taped the needle in place. Staff (F) reset the machine alarm and without changing gloves or performing hand hygiene. Staff (F) removed the old dressing from the central venous catheter exit site and ports. Upon completion of catheter care, Staff (F) then removed their gloves but did not perform hand hygiene prior to exiting the station. Observation on 08/21/24 at 12:20 PM revealed Staff (J), Patient Care Technician, entered Station #2 and applied a pair of clean gloves, but did not perform hand hygiene. Staff (J) proceeded to assist in the cannulation of Patient #10. Observation on 08/21/24 at 12:22 PM revealed Staff (F), Registered Nurse, changed their gloves but did not perform hand hygiene to administer Patient #10 heparin bolus. Observation on 08/21/24 at 04:00 PM at Station #2 for Patient #10 revealed Staff (F), Registered Nurse held the handle of the sharps’ container on wheels with ungloved hands, and brough it to Station #10. Staff (F) did not perform hand hygiene, applied a clean pair of gloves, assisted Patient #10 with applying their face mask, and placed Patient #10 walker in front of Patient #10 to stand for a blood pressure. Observation on 08/23/24 at 10:30 AM at Station #3 for Patient #15 revealed Staff (B), Nurse Manager, touched the machine with gloves, disconnected the arterial blood line (pulls blood from the patient to the dialysis machine) from Patient #15, and connected it to the normal saline line port to return Patient #15’s blood back to discontinue treatment. Staff (B) touched the hemodialysis machine multiple times during the discontinuation of treatment and disconnected the venous blood line (returns blood to the patient) from Patient #10. Staff (B) removed the blue Hansen connector (supplies dialysate fluid to the artificial kidney or dialyzer used remove toxins from a patient’s bloodstream) from the dialyzer. Staff (B) continued with post treatment catheter care without changing gloves or performing hand hygiene. Observation on 08/23/24 at 11:50 AM at Station #2 for Patient #10 revealed Staff (B), Nurse Manager reset the hemodialysis machine alarm, removed gloves, but did not perform hand hygiene. Staff (B) exited the station to retrieve a syringe from the common supply area. Staff (B) re-entered Station #2 without performing hand hygiene and applied a pair of clean gloves to check the fistula (surgically created access for dialysis) needle placement and reset the machine alarm. At 11:55 AM after performing an assessment at Station #3 for Patient #14, Staff (B) entered Station #2 for Patient #10, applied a pair of clean gloves without performing hand hygiene, and reset the hemodialysis machine that was alarming. Staff (B) removed the gloves and applied a new pair of clean gloves without performing hand hygiene, and proceeded to apply a face shield, reset the hemodialysis machine alarm, and to check placement of Patient #10’s fistula arterial needle. At 12:00 PM at Station #6 for Patient #6, Staff (B) did not perform hand hygiene after typing on the mobile cart/computer keyboard. Staff (B) applied a clean pair of gloves, exited Station #6 with gloves on to retrieve their face shield located in a common area in the center of the unit. Staff (B) returned to Station #6 with the same gloves on, applied their face mask, touched the hemodialysis machine, and removed the old dressings covering the catheter exit site and ports. Staff (B) changed gloves but did perform hand hygiene prior to applying clean gloves to continue with catheter care. Review of the policy “Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles,” last revised April 2023 indicated when a patient holds their own canulation sites, the patient will be offered gloves, and to perform hand hygiene when completed. Observation on 08/23/24 at 09:50 AM at Station #2 revealed Patient #8 held their needle insertion sites after the removal of both needles while wearing a glove but did not wash hands after treatment. Observation on 08/23/24 at 10:25 AM at Station #8 revealed Patient #13 held their needle insertion sites after the removal of both needles while wearing a glove but did not wash hands after treatment. Interview on 08/23/24 at 01:30 PM with Staff (O), Regional Coordinator, and Staff (H), Facility Administrator, verified these findings.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 16136 Based on observation and interview, the facility does not ensure that the regulated medical waste room was secure. Findings include: Observation on 08/21/24 at 10:05 AM revealed that the regulated medical waste room, located in the corridor adjacent to a marked exit, was not secured. The room was not supervised and did not have a locking device that would restrict unauthorized access. Interview on 08/21/24 at 10:10 AM with Staff (K), Bio Medical Technician, verified this finding.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 40430 Based on policy review, observation, and interview, nursing staff did not ensure that aseptic technique was used to prepare intravenous medications, as required. Findings include: Review of the policy “Preparation and Administration of Parenteral Medications (Non-Esa, Non-Parsabiv),” last revised April 2024, indicated that if the medication is in a vial, remove the vial cap, and clean vial stopper with an alcohol prep pad. A new alcohol prep pad is used prior to each time the vial is entered. Observation on 8/23/24 at 09:00 AM revealed Staff (B), Nurse Manager was drawing up and preparing heparin (medication used to prevent blood clotting during dialysis) syringes for the second shift of patients. Staff (B) did not use an alcohol pad to clean the vial stopper each time the vial was entered for ten syringes of heparin. At 09:15 AM, Staff (B) removed the vial cap from two vials of Parsabiv (medication used to treat overactive parathyroid gland that secretes a hormone that regulates calcium, phosphorus, and magnesium levels in the blood and bones) but did not clean the vial stoppers with an alcohol prep pad prior to drawing up the medication into two separate syringes. Interview on 08/23/24 at 01:30 PM with Staff (O), Regional Coordinator, and Staff (H), Facility Administrator, verified these findings.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 16136 Based on policy review, observation, and interview, the facility does not ensure adequate separation between three different acid concentrations (concentrate that is mixed with purified water and bicarbonate concentrates in the dialysis machine) located in the supply room. Findings include: Review on 08/23/24 of the policy “1-02-03 Look Alike, Sound Alike Product Storage and Labeling,” last reviewed 04/2019, indicated care should be taken when products or containers that look alike, sound alike are stored in the facility. Ways to identify and label look alike, sound alike items may include: if possible, one type of solution per shelf, dividers between different solutions if the shelf has to be shared, brightly colored labels are used for different solutions, and labeling the outer covering of solution with the content identified and any other method which distinctly identifies the different solutions. Items which require labeling include but are not limited to acid concentrates. Observation on 08/23/24 at 11:15 AM in the supply room revealed different concentrations of one-gallon acid jugs were stored together on pallets. The acid concentrations were 2.0K/3.0 Ca, 3.0K/3.0 Ca, and 4.0K/3.0 Ca. No dividers, labels, or other means to differentiate the jugs for the three different concentrations of acid was noted. Interview on 08/23/24 at 11:20 AM with Staff (K), Biomedical Technician, verified this finding.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, staff did not ensure monthly water cultures are obtained prior to water loop disinfection for 2 of 12 months (04/2024 and 06/2024). Findings include: Review on 08/22/24 of the policy “1-19-01 Water Culture Policy, “ last revised 04/2024, indicated that routine water cultures are collected monthly within 72 hours prior to the scheduled disinfection of the distribution system. Review on 08/22/24 of the reports for water cultures and the “Water Loop Disinfection Log,” revealed on 04/19/24, water cultures were drawn and on 04/19/24 the water loop was disinfected. On 06/04/24, water cultures were drawn and the on 06/04/24 the water loop was disinfected. No time was documented to indicate that the water cultures were drawn prior to the water loop disinfection. Interview on 08/23/24 at 12:55 PM with Staff (K), Bio Medical Technician, verified this finding.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 16136 Based on observation and staff interview, the facility does not ensure a safe environment in the clinic setting for patients, staff, and the public. Specifically, fire doors are propped open, staff do not have emergency access for two of two patient toilet rooms, and the eye wash station was obstructed for use. Findings include: Observation on 08/21/24 at 09:50 AM and again on 08/23/24 at 09:00 AM revealed the fire door located adjacent to the patient toilet room in the clinic area was propped open with a “chuck (a floor device to hold doors open).” Fire doors need to be closed per the National Fire Protection Association - 2010 edition. Observation on 08/21/24 at 10:05 AM revealed two of two patient toilet rooms did not provide emergency access to staff in the event of a patient emergency. The doors need to be equipped with emergency access hardware, a key place at the door or all staff must have in their possession a key to open the toilet room to gain access in an emergency per the Facility Guideline Institute - 2010 edition. Observations on 08/23/24 at 09:10 AM revealed the eye wash station in the clinic area, across from Station #6, was obstructed by a regulated medical waste bin, a trash can, and a patient wheelchair. The eye wash station needs to be accessible for usage per the Facility Guideline Institute - 2010 edition. Interview on 08/23/24 at 09:45 AM with Staff (K), Bio Medical Technician, verified these findings.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 16136 Based on document review, observation, and interview, the facility does not ensure that the fire alarm system is maintained. Specifically, required testing was not performed for the fire system strobe devices, Sealed Lead Acid Battery, and fire dampers. Fire extinguishers were not easily identified for usage, and the sprinkler system was not maintained properly. Findings include: Review on 08/21/24 at 11:15 AM of the “2022 Fire Alarm Inspection and Testing Form,” revealed no evidence the 13 horn/strobe devices/strobe devices (part of the fire alarm system) were tested annually and the Sealed Lead Acid battery ( batteries that are designed to be maintenance free and do not require the user to add water to the cell and spill proof.) had been tested semi-annually per the National Fire Protection Association- NFPA 72, 2010 edition. Testing was last performed in 10/2019. Interview on 08/23/24 at 1:00 PM with Staff (K), Bio Medical Technician, verified this finding. Observation on 08/22/24 at 01:00 PM revealed six fire extinguishers are located throughout the clinic area. There was no signage identifying the extinguishers and their locate required by the National Fire Protection Association- NFPA 10 - 2010 edition to alert staff and patients for access in the event of an actual fire emergency. Interview with Staff (H), Facility Administrator, verified this finding. Observation on 08/23/24 between 09:20 AM and 11:00 AM revealed four fire dampers (prevents fire, heat, and smoke from spreading to different areas of the facility) were in one-hour fire-rated walls. Two of these dampers were located above the ceiling tiles in the soiled utility room and two dampers were located above the ceiling tiles in the bicarb/water room. No documentation was found to indicate required inspection/testing of the dampers was conducted one year after installation and then every four years per the National Fire Protection Association- NFPA 80, 2010 edition. Interview with Staff (K), Bio Medical Technician, verified this finding. Observation on 08/23/24 at 11:10 AM revealed two red wires, two gray wires and one blue wire was supported by the sprinkler lines above the ceiling tiles in the conference room; two yellow wires were supported by the sprinkler line above the ceiling tiles in the exam room; a gray and white wire and corrugated conduit was supported by the sprinkler line above the ceiling tiles in home therapy; and two heating/ventilation/air conditioning supply duct work were supported by the sprinkler lines above the ceiling tiles in the bicarb area. Sprinkler piping or hangers shall not be used to support non-system components per the National Fire Protection Association 25 - 2011 edition. Interview on 08/23/24 at 11:20 AM with Staff (K), Biomedical Technician, verified these findings.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 40430 Based on policy review, medical record review, and interview, nursing staff did not ensure dialysate (fluid passing through the artificial kidney or dialyzer used for to remove toxins from a patient’s bloodstream) flow rates and blood flow rates are implemented and/or maintained according to the physician order for four of six hemodialysis patients (Patient #3, #6, #7, and #9). Findings include: Review of the policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised April 2024, indicated if the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate), the reason will be documented, and the licensed nurse will be informed. Review on 08/22/24 of the hemodialysis flowsheets for Patient #3 dated from 07/29/24 to 08/21/24, revealed a prescribed dialysate flow rate of 800 milliliters per minute (ml/min). The dialysate flow rate was not maintained on 07/31/24 and 08/09/24. There was no documentation in the medical record to indicate why the dialysate flow rate was not maintained as ordered. Review on 08/22/24 of the hemodialysis flowsheets for Patient #6 dated from 07/22/24 to 08/21/24, revealed the prescribed blood flow rate of 350 ml/min. The blood flow rate was not maintained on 07/29/24. There was no documentation in the medical record to indicate why the blood flow rate was not maintained as ordered. Review on 08/22/24 of the hemodialysis flowsheets for Patient #7 flowsheets dated from 07/29/24 to 08/21/24, revealed the prescribed blood flow rate of 400 ml/min. The blood flow rate was not maintained on 08/19/24. There was no documentation in the medical record to indicate why the blood flow rate was not maintained as ordered. Review on 08/22/24 of the hemodialysis flowsheets for Patient #9 dated from 07/29/24 to 08/21/24, revealed the prescribed dialysate flow rate of 800 ml/min. The dialysate flow rate was not maintained on 08/16/24 and 08/19/24. There was no documentation in the medical record to indicate why the dialysate flow rate was not maintained as ordered. Interview on 08/23/24 at 01:30 PM with Staff (O), Regional Coordinator, and Staff (H), Facility Administrator, verified these findings.”

“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: 40430 Based on policy review, medical record review, and interview, nursing staff did not assess post treatment standing blood pressure, as required, for three of six hemodialysis patients (Patient #3, #7, and #9). Findings include: Review of the policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised April 2024, revealed that patient data/vital signs will be documented by the patient care technician or a licensed nurse to include standing blood pressure measurements pre and post treatment (if patient is unable to stand, document reason in the patient electronic record or flow sheet). Review on 08/22/24 of hemodialysis treatment flowsheets revealed no evidence of post treatment standing blood pressures for the following patients: Review on 08/22/24 of the hemodialysis flowsheets for Patient #3 flowsheets dated from 07/29/24 to 08/21/24, revealed no documented of a post treatment standing blood pressure on 07/31/24. No reason was listed, and mobility was documented as ambulatory with ambulatory device (walker) needed. There was no documentation in the medical record to indicate Patient #3 refused a standing blood pressure. Review on 08/22/24 of the hemodialysis flowsheets for Patient #7 dated from 07/29/24 to 08/21/24, revealed no documented post treatment standing blood pressure on 08/12/24. No reason was listed, and mobility was documented as ambulatory with no assistance needed. There was no documentation in the medical record to indicate Patient #7 refused a standing blood pressure. Review on 08/22/24 of the hemodialysis flowsheets for Patient #9 dated from 07/29/24 to 08/21/24, revealed no documented post treatment standing blood pressure on 08/12/24. No reason was listed, and mobility was documented as ambulatory with no assistance needed. There was no documentation in the medical record to indicate Patient #9 refused a standing blood pressure. Interview on 08/23/24 at 01:30 PM with Staff (O), Regional Coordinator, and Staff (H), Facility Administrator, verified these findings.”