Davita Lakeside Dialysis

“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: 44367 Based on observations and review of the facility’s policies, the governing body failed to ensure that patient nutritional supplements/medications were kept in a clean area of the facility separate from the dirty areas. This failure put the patients at risk of cross-contamination of infectious diseases, which may cause harm. Findings include: Review on 02/27/2024 of the facility’s policy 1-05-01 entitled “Infection Control for Dialysis Facilities” stated that, “If a common supply car is used to store clean supplies in the patient treatment area, this cart is to remain in a designated are at a sufficient distance from patient stations to avoid contamination of blood...Clean areas should be clearly designated for the preparation, handling, and storage of medication and unused supplies and equipment. Clean area should be clearly separated from contaminated areas where used supplies and equipment are handled.” Inspection of the clinical treatment area on 02/27/2024 at 10:41 a.m. revealed six a three (3) tier open cart was used for medication storage and preparation and supplies. The three tier cart was position directly behind the occupied hemodialysis station 12 and 13. The facility did not have a splash guard (device used to prevent contamination from blood splatter) in place to protect medication and supplies from possible contamination. The facility Administrator was informed and agreed with the findings on 02/28/2024.”

“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: 44367 Based on observations and a review of the facility’s policies and procedures, the governing body failed to ensure that the clinical staff disinfected the hemodialysis machines and stations after the patient has completely vacated the station. This failure placed the patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Staff: #3 Findings included: Review on 02/28/2024 of the facility’s policy 1-05-01 entitled “Infection Control for Dialysis Facilities” revealed that the, “Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient.” 1. On 02/28/2024 at 01:45 p.m., Staff #3 cleaned and place the clean supplies on top of the dialysis machine for the next patient at station 12, while the current patient was holding access to stop the bleeding. The Facility Administrator was informed of the findings on 02/28/2024.”

“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: 44367 Based on observations and review of the facility’s policies and procedures, the governing body and the medical director failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #4, #5 and #9 Findings include: According to the National Institute of Health (NIH), “A central venous catheter (CVC) is an indwelling device inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium [parts of the heart].” Review of the facility’s policy 1-04-02B entitled “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps” states to “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason.” The policy also states, “Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly... “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 ...Then wait 60 seconds for air dry time.” 1. During observation of the clinical treatment area on 02/28/2024 at 11:03 a.m., during initiation of treatment of a CVC patient at station 2, Staff #4 did not clean the venous or arterial hub after removing the caps and before attaching a clean 10 ml syringe. Staff #4 cleaned the exit site for 6 seconds and only allowed the site to dry for 30 seconds prior to placing a clean dressing. The Facility Administrator was informed of the findings on 02/28/2024.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 44367 Based on observations and interviews with the facility staff, the facility administrator and medical director failed to ensure the water purification and storage system was only accessed by authorized personnel. This failure had the potential to place all patients at potential risk of harm from unauthorized access to the water treatment system. Findings include: Review on 02/28/2024 of the facility’s policy 2-07-01 “Bicarbonate Concentrate system Mixing” revealed, “All deliveries made in close proximity to the bicarbonate delivery system must be supervised.” During observation of the clinical treatment area on 02/28/2024 at 10:57 a.m., the surveyor observed a person presenting as a delivery driver put the code in the locked door and gained access to the water treatment system and supplies.The unauthorized person was allowed to enter the water treatment room without supervision from the facility’s personnel. The Facility Administrator observed and corroborated the findings on 02/28/2027 at 10:57 a.m.”

“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: 44367 Based on observation and review of the facility’s policies and procedures, the facility’s administration failed to ensure that the facility provided and maintained a safe treatment environment for its patients by ensuring the facility conduct fire drills quarterly per the facility’s policy.This failure placed the patients and visitors at potential risk of harm in the event of a fire. Review on 02/28/2024 of the facility’s policy 4-07-01 entitled “Facility Emergency Management Plan” revealed, “Fire safety drills: Required on a Quarterly basis.” During review of the emergency preparedness binder on 02/28/2024, the surveyor noted that the facility conducted a fire drill on 09/07/2023 and 09/08/2023. There were no fire drills documented before 09/07/2023 or after 09/08/2023. The Facility Administrator was given the opportunity to provide additional information however, no additional documentation was provided. The Facility Administrator corroborated that the facility has not conducted fire drills quarterly as required per policy. The Facility Administrator was informed of the findings on 02/28/2024.”

“PR-CAN HAVE ADVANCE DIR,TOLD FAC AD P&P CFR(s): 494.70(a)(6) The patient has the right to- (6) Be informed about his or her right to execute advance directives, and the facility ’ s policy regarding advance directives; This Standard is not met as evidenced by: 44367 Based on medical record review, the facility administrator and medical director failed to ensure that all of the facility’s patients had a completed Medical Orders for Life-Sustaining Treatment Form (MOLST) on their patient records and was given information about creating an advance directive in a prompt manner. This failure denied the patients their rights to formulate treatment decisions that served their end of life needs. Patients: #1, #3 and #4 Findings included: According to maryland.gov on 02/28/2024, “MOLST forms must be completed for newly admitted patients during the admission process in all assisted living programs, home health agencies, hospices, kidney dialysis centers, and nursing homes.” Review on 02/28/2024 of the facility’s policy 3-02-19 “MOLST Form” revealed “This is a document that must be prepared for each patient.” A review of the medical records on 02/28/2024 revealed that two (2) out of seven (7) or 30% of the selected patients selected did not have a MOLST form in their chart. Patient #1 was admitted on 02/10/2024. No MOLST form was found in Patient #1’s chart. Patient #3 was admitted on 12/01/2023. No MOLST form was found in Patient #3’s chart. Patient #4 was admitted on 04/22/2021. No MOLST form was found in Patient #4’s chart. The Facility Administrator was informed of the findings and given the opportunity to provide the completed MOLST forms on 02/08/2024; However no documentation was provided.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 44367 Based on record review of medical records, the Facility’s Administration and the Medical Director failed to ensure that initial nursing assessments were performed by the assigned registered nurse prior to the patients’ initial dialysis treatment when being admitted to the facility. This failure placed the affected patient(s) at risk for receiving insufficient and ineffective care and denied the patients their rights. Patient: #2, #4 and #7 Findings included: The facility’s policy 1-03-07 “New Patient Pre-Treatment Evaluation” page 1 states, “An RN, as required by federal regulation, will perform an initial pre-treatment evaluation of all new patients prior to the initiation of their first treatment at the facility.” During inspection of the patients’ charts on 02/28/2024, the surveyor noted that 3 out of the 7 (43%) selected patients did not have an initial nursing assessment or the assessment was completed after the first treatment. Patient #2 was admitted on 08/02/2019. No initial nursing assessment was found in the patients chart. Patient #4 was admitted on 04/22/2021. No initial nursing assessment was found in the patients chart. Patient #7 was admitted on 01/23/2007. No initial nursing assessment was found in the patients chart. The Facility Administrator was informed of the findings and given the opportunity to provide the initial nursing assessments on 02/28/2024; However no documentation was provided.”

“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: 47759 Based on observations, interviews and record reviews, the facility’s governing body failed to maintain an environment free from infestations. This failure placed patients at potential risk of infection and denied their rights to a minimum standard of medical care. Findings Included: According to a pest control company Orkin, “Biting Gnats Bites are most likely to occur on any exposed, uncovered skin and most often occur on the head, neck, forearms, hands, face, legs and feet. General symptoms are itchiness, irritation, redness and swelling at the site of the bite ... Continuous scratching can lead to open sores that are susceptible to secondary bacterial infection of the bite wound. In some cases, the transmission of infectious diseases by the biting gnat is possible.” On 12/08/2023, during observations from 10:00 a.m. -11:00 a.m., the surveyor observed four (4) unknown types of insects flying with a comparable size to a single piece of sesame seed. One of the insects was observed constantly flying around the surveyor’s forehead and neck in the conference room. On 12/08/2023, during interviews with staff members, Staff #1, #2 and #3 were asked the question “What types of patient concerns or complaints have you had to respond to, report and record?” The responses received were as follows: 1. At 11:10 a.m., Staff #2 stated “gnats ...It’s kinda bad.” “I think it’s coming from the drainage” 2. At 11:15 a.m., Staff #1 stated “gnats ...it’s been months.” “I think it’s coming from the drainage.” “We have poured chemicals, but it’s not resolving the issue.” 3. At 11:20 a.m., Staff #3 stated “gnats. It’s been years, they’re especially worse during winter. The gnats lay eggs. They’re in the treatment floor, water room, breakroom, or even office.” “I think they’re coming from the vent.” When asked the question, was management made aware? three (3) out of the three (3) staff members stated “Yes.” On 12/08/2023, during interviews with patients, Patients #1, #2, #3 and #4 were asked the question “How clean, comfortable and safe do you feel in the facility?” 2 out of the 4 patients brought up the issue with “gnats.” The shortened responses received were as follows: 1. At 10:50 a.m., Patient #2 stated, “There are gnats in this facility and they are flying everywhere.” 2. At 10:50 a.m., Patient #3 stated “there are gnats that are flying around and I think they are coming from the water supply.” On 12/08/2023, at 11:40 a.m., during record review, it was revealed that a complaint about gnats has been filed 3 times. It has been filed 11/02/2023, 08/16/2023, and 07/25/2022 by Patient #5.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 47759 Based on record review and staff interview, the facility’s governing body failed to ensure that all grievances are being filed, resolved, trended and presented in Quality Assurance and Performance Improvement (QAPI). This failure poses a potential risk of safety to the patients and denies patients their rights to a minimum standard of medical care. Findings Included: On 12/13/2023 at 04:24 p.m., during record review of the facility’s policy, policy 3-01-06A, “Addressing Patient grievances: DaVita Teammates” page 1 number 3 states “All details of patient grievances and discussions will be documented.” Number 5 states “based on the nature of the complaint, the appropriate member of the interdisciplinary team (IDT) will discuss the grievance with the patient and take appropriate action towards a solution, if possible.” Number 6 states “If the patient grievance cannot be resolved, the Facility Administrator (FA) will be notified. The FA will meet with the patient to discuss the grievance and take appropriate action towards a solution, if possible. If the grievance is not resolved, the patient should be invited to a grievance conference. The grievance conference should be coordinated to occur within 10 days of receipt of the complaint.” On 12/08/2023, at 11:40 a.m., during record review, it was revealed that a complaint about gnats has been filed 3 times. It has been filed 11/02/2023, 08/16/2023 and 07/25/2022 by Patient #5. Upon further review of each complaint, the surveyor observed that there was no resolution filed for the complaint filed on 08/16/2023. On 12/08/2023 at 11:50 a.m, during interviews with the Facility Administrator (FA), the FA corroborated that [he/she] could not find the resolution documentation for the complaint filed by Patient #5 on 08/16/2023. On 12/12/2023 at 01:00 p.m., during a phone interview with the Social Worker, the surveyor asked the Social Worker if Patient #5 ‘s complaint filed on 11/02/2023 has been resolved. The Social Worker stated “No, not resolved that day. I had to give it to the FA because it was not a problem that I could fix myself.” As a follow up question, the surveyor then asked the Social Worker if there was ever a grievance conference that occurred? The answer was no. On 12/12/2023 at 12:50 p.m., during a phone interview with the FA, the surveyor asked the FA if Patient #5’s most recent complaint has been resolved? The FA re-directed the surveyor to the Social Worker. As a follow up question, the FA was then asked if the complaint filed about gnats was discussed in QAPI and the answer was no.”

“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: 47759 Based on staff interviews and record reviews, the facility’s governing body failed to ensure that facilities discuss problems that have been identified in the facility, taking into account the prevalence, severity and prioritizing improvement activities. This failure compromised the opportunity to improve the quality of care being provided at the facility and denied patients’ their rights to a minimum standard of medical care. Findings Included: On 12/08/2023, at 12:00 p.m., during record review, when the surveyor asked for the data, trend, analysis and action plan gathered about the “gnat” issue in the facility documented in QAPI and/or governing body, the Facility Administrator was not able to present the data to the surveyor. 1. The surveyor asked for the monthly data collection that the facility uses to track the presence of gnats. No documentation could be presented to the surveyor at the time of the survey. 2. The surveyor asked for the monthly treatment plan evaluation discussion. No documentation could be presented to the surveyor at the time of the survey. 3. The surveyor asked for the pest control involvement evidence such as invoices, however, no invoice could be presented to the surveyor at the time of the survey. 4. The surveyor asked for the Air Conditioner Duct Inspection report, however, no documentation could be presented to the surveyor at the time of the survey. On 12/08/2023, at 01:10 p.m., during interviews with the Facility Administrator (FA), the FA corroborated that [he/she] should have discussed and documented identified issues in the facility in their Facility Health Meeting (FHM) also known as Quality Assurance and Performance Improvement (QAPI)”