Davita Forest Landing Dialysis

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 47759 Based on the overall findings of this survey, it was determined that the facility’s governing body failed to ensure that facility Staff #1, #2 and #3 operated dialysis machines in compliance with the manufacturer’s recommendations as evidenced by: 1. Failure to assemble the required safety components of the dialysis machine prior to testing as outlined in the manufacturer’s instructions. 2. Failure to remove dialysis machines from service after they failed subsequent tests, as required by the manufacturer’s instructions. And 3. Failure to adhere to the manufacturer’s troubleshooting procedures and recommended steps as outlined in the manufacturer’s instructions for dialysis machines. These failures placed the affected patients at potential risk of serious injury, serious harm and possible death and resulted in the determination that the facility was out of compliance with the Condition for Coverage for Physical Environment (CfC: 494.60). Findings included: 1. The facility’s governing body failed to ensure that staff operated dialysis machines in accordance with the manufacturer’s recommendations. Cross Reference: Physical Environment-Safe/functional/comfortable environment (V0403)”

“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: 47759 Based on interviews and observations, the facility’s governing body failed to ensure that infection control practices were consistently adhered to by clinical staff members, as evidenced by personal protective equipment (PPE) stored alongside personal items and residual medical tape affixed to armchairs. This failure placed patients, staff, and visitors at an increased risk of healthcare-associated infections. Findings Included: Between 07/30/2025 and 08/04/2025, during observations of the treatment floor, the surveyor observed the following: 1. On 07/30/2025 at 09:10 a.m., the surveyor, together with the Facility Administrator observed a PPE (Gown) of Staff #3 hung alongside three regular wear jackets. a. Interviews with the Facility Administrator indicated that the jackets belonged to staff members and would be promptly removed from the treatment floor 2. On 08/04/2025 at 12:15 p.m., the surveyor, together with the Manager of Clinical Services, observed residual medical tape affixed to the armchairs after disinfection, as well as brownish discoloration remaining after disinfection at Stations #5, #6, #18, #19, and #20 a. Interviews with the Manager of Clinical Services corroborated that the medical tape affixed to the armchairs along with the brownish discoloration posed infection control risk and stated that it would be addressed immediately.”

“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: 47759 Based on record review, interviews and observations, the facility’s governing body failed to ensure that personal protective equipment (PPE)’s were worn by visitors when in the treatment area. This failure posed a risk of exposure to infectious diseases and blood borne pathogens to other staff members, as well as patients. Findings Included: On 08/06/2025 at 03:20 p.m., during review of the facility’s policies and procedures titled “Infection Control for Dialysis Facilities” (Policy 1-05-01), page 2 number 5 stated: “Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces, for example, patient care areas.” Number 6 stated: “Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, Physicians and Non-Physician (NPP) and visitors when in the treatment area.” On 08/04/2025 at 12:55 p.m., the surveyor observed two family members assisting a patient on the treatment floor without wearing personal protective equipment (PPE). According to Staff #3, it is not the facility’s practice to require family members to wear PPE on the treatment floor. According to the Manager of Clinical Services, if there is the potential for contact with contaminated equipment, then PPE must be worn.”

“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: 47759 Based on observations, review of policies and procedures and staff interview, the facility’s governing body failed to ensure that clean supplies and medications were stored in a manner that protected them from potential sources of contamination. This failure placed patients at risk of exposure to infectious diseases and blood borne pathogens to patients. Findings Included: On 08/06/2025 at 03:20 p.m., during review of the facility ’ s policies and procedures titled “ Infection Control for Dialysis Facilities “ (Policy 1-05-01), page 5 number 16 stated: “ Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. “ Page 5 number 19 letter b stated: “ Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place. “ On 08/04/2025, during observations of the treatment floor, the surveyor observed the following: 1. The surveyor observed 2 prepared syringes containing a medication called heparin placed adjacent to the sink by Station #17. 2. The surveyor observed several clean items such as transducer protector, blood luer lock, patient thermometer, among other items placed adjacent to the hazard and trash container. 3. The surveyor observed items spread out across the countertops. a. According to the Manager of Clinical Services, the countertops need to be decluttered.”

“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: 47759 Based on observations and staff interviews, the facility’s governing body failed to ensure that potentially infectious wastes were transported in a manner that promotes safe handling and proper disposal. This failure placed the staff and patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Staff #2 Findings Included: On 07/30/2025, at 09:53 a.m., during observations of the treatment floor, the surveyor observed Staff #2 transport two uncapped syringes containing blood from Station #15 to the sharps disposal container located near Station #17. On 08/06/2025, interviews with the Manager of Clinical Services stated that staff members should not carry contaminated items from one station to another for disposal.”

“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 ensure that machine hand cranks were readily available at all stations in the event of an emergency. This failure placed the patients at potential risk of harm including blood loss in case of a power outage. Findings included; On 08/04/2025, during review of the facility’s policy titled “Physical Environment” (Policy 08-04-01) page 1 number 1 stated: “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment.” Review of the Fresenius 2008K2 Machine Operator ’ s Manual, page 43 stated: “ Ensure the emergency hand crank for the blood pump is available. “ Page 119 stated: “ In the event of a power failure during treatment, the 2008K blood pump can be manually operated to return the blood to the patient. “ On 07/30/2025, between 12:30 p.m. - 01:00 p.m. during observations of the treatment floor: 1. The surveyor, together with the Manager of Clinical Services, observed that 5 out of the 24 stations did not have machine hand cranks readily available for emergency use. a. Interviews with the Manager of Clinical Services stated that she will immediately request for more hand cranks.”

“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: 47759 Based on observations, staff interviews, and record review of facility’s policies and procedures, the facility’s governing body failed to ensure that facility Staff #1, #2 and #3 operated dialysis machines in compliance with the manufacturer’s recommendations as evidenced by: 1. Failure to assemble the required safety components of the dialysis machine prior to testing as outlined in the manufacturer’s instructions. 2. Failure to remove dialysis machines from service after they failed subsequent tests, as required by the manufacturer’s instructions. And 3. Failure to adhere to the manufacturer’s troubleshooting procedures and recommended steps as outlined in the manufacturer’s instructions for dialysis machines. These failures placed the affected patients at potential risk of serious injury, serious harm, and possible death. Findings Included: 1. On 07/28/2025 at 12:35 p.m., during review of the Fresenius 2008K2 Machine Operator’s Manual, page 193 stated: “Warning! The tubing beneath the venous drip chamber must be inserted into the venous line clamp and the optical detector.” a. On 07/28/2025, between 10:10 a.m. -10:40 a.m., during observations of the treatment floor, the surveyor observed the following: i. Staff #1 tested dialysis machine #17 located at Station #11 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). Once the test concluded, Staff #1 stated that the machine was ready for patient use. ii. Staff #2 tested dialysis machine #26 located in Station #15 without inserting the tubing beneath the venous line clamp and the optical detector (air detector). Once the test concluded, Staff #2 stated that the machine was ready for patient use. iii. At 10:20 a.m., the Facility Administrator corroborated that Machines #17 and #26 did not have the tubing beneath the venous drip chamber properly inserted into the venous line clamp and the optical detector (air detector). b. At 11:00 a.m., interviews with the Clinical Coordinator stated that the tubing beneath the venous drip chamber must be inserted into the venous line clamp and the optical detector prior to testing. 2. On 07/28/2025 at 12:35 p.m., during review of the Fresenius 2008K2 Machine Operator’s Manual, page 55 stated: “Warning!...If the machine fails this or any of the Pressure, Alarm, and Diasafe tests and the cause cannot be corrected, or if it fails subsequent tests, it should not be used for treatment. Remove the machine from service and have it inspected by a qualified technician to correct the problem.” a. On 07/28/2025, between 10:41 a.m. -10:50 a.m., during observations of the treatment floor, the surveyor observed that machine #26 located at Station #15 failed the optical detector test 2 times. The surveyor then observed Staff #2 retest the machine the 3rd time. b. At 10:55 a.m., the Facility Administrator stated that Machine #26 located at Station #15 should have been pulled out of service once it had failed two times. c. Between 10:50 a.m., -11:10 a.m., Interviews conducted with Staff #2 and Staff #4 revealed that they would pull the machine out of service after the machine had failed three consecutive times. d. Interviews with the Facility administrator and the Clinical Coordinator stated that according to policy, machines should be pulled out of service once it had failed two times. 3. On 07/28/2025 at 12:35 p.m., during review of the Fresenius 2008K2 Machine Operator’s Manual, page 148 stated that in case of an air detector alarm, the action required are as follows: “1.) Inspect the venous drip chamber and level detector module to see if: -There is an adequate level of blood (approximately ¾ full) in chamber-The venous drip chamber is properly mounted in its holder. -The venous drip chamber is positioned with the mesh filter below the level detection sensors. -The sensors are clean (if not, clean with an alcohol pad) -The Level Detector door is closed and latched. 2.) Raise blood level by pressing and holding the (up) key on the level detector until the chamber is approximately ¾ full. 3.) Press the reset key to reset the alarm. If unable to reset the alarm, return the blood to the patient and take the machine out of service. Have a qualified service technician recalibrate for the type of bloodline used.” a. On 07/28/2025, between 11:35 a.m.- 11:40 a.m., the surveyor observed the following: i. At 11:36 a.m., Staff #2 reset the dialysis machine alarm-identified as “Air Detector Alarm” on Machine #18, located at Station #15 at least 3 times. The surveyor then intervened and asked Staff #3 to help Staff #2 with the machine alarm. During this time, Staff #2 continued to press the reset button at least 4 more times. Staff #3 intervened and continued to reset while also troubleshooting the machine. The surveyor asked the Facility Administrator to intervene and Staff members #2 and #3 were instructed to take the machine out of service. 4. On 07/28/2025 at 02:17 p.m., the Office of Health Care Quality (OHCQ) issued an Immediate Jeopardy due to failure to ensure that facility Staff #1, #2 and #3 operated dialysis machines in compliance with the manufacturer’s recommendations as evidenced by: 1. Failure to assemble the required safety components of the dialysis machine prior to testing as outlined in the manufacturer’s instructions. 2. Failure to remove dialysis machines from service after they failed subsequent tests, as required by the manufacturer’s instructions. And 3. Failure to adhere to the manufacturer’s troubleshooting procedures and recommended steps as outlined in the manufacturer’s instructions for dialysis machines. On 07/30/2025 at 03:00 p.m., a survey team member verified that the facility implemented the acceptable IJ removal plan, which included the following actions: a. Completion of In-services to all teammates with emphasis on: i. the proper assembly of the required safety components prior to testing as outlined in the manufacturer’s instructions. ii. adherence to the manufacturer’s troubleshooting procedures and recommended steps as outlined in the manufacturer’s instructions. iii. adherence to the manufacturer’s recommended steps after subsequent machine failure as outlined in the manufacturer’s instructions. b. Completion of audits of all machines each shift to verify proper setup, testing, and response to alarms. c. Completion of daily meetings with the governing body to monitor progress toward 100% compliance with manufacturer instructions for dialysis machine setup, safety testing, and alarm troubleshooting.”

“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: 47759 Based on observations and record reviews, the facility’s governing body failed to ensure that the dialysis prescriptions were the same as what the patients received. This failure placed the patients at potential risk of harm or injury. Findings Included: On 08/04/2025, during review of the facility’s policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment “ (Policy 08-04-01), page 2 number 3 stated, “ Patient identity, prescription and machine settings are verified by teammate ... within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate (DFR) “ Page 4 number 10 stated “ 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 informed. “ Definition: Ultrafiltration Rate (UFR) is a clinical rate, set by the provider, at which fluid is removed from a dialysis patient’s blood during treatment. Dialysis Flow Rate (DFR) is a clinical rate, set by the provider, that specifies the speed at which the dialysate (cleansing fluid) flows through the dialyzer. On 08/04/2025 between 10:00 a.m. -12:00 p.m., during treatment flowsheet review, the surveyor observed the following: 1. Review of Patient A’s treatment flowsheet on treatment date 07/30/2025 revealed that the patient had a maximum UFR order of 13 mL/kg/hr. a. Review of the treatment flowsheet revealed that Ultrafiltration rate was turned off from 11:01 a.m. 01:05 p.m. No supporting documentation was found notifying the nurse of the situation. 2. Review of Patient C’s treatment flowsheet on treatment date 07/28/2025 revealed that the patient had a maximum UFR order of 13 mL/kg/hr. a. Review of the treatment flowsheet revealed that Ultrafiltration rate was turned off from 05:35 a.m. -07:59 a.m. No supporting documentation of nurse reassessment was found. 3. Review of Patient F’s treatment flowsheet on treatment date 07/25/2025 revealed that the patient had a DFR order of 800 mL/min. a. Review of the treatment flowsheet revealed that the DFR was documented as 500 mL/min from 10:08 a.m. -01:31 p.m. No supporting documentation was found explaining why the DFR prescription was not followed. On 08/04/2025 interviews with the Facility Administrator indicated that, per facility policy, staff members are required to document any instance in which a patient’s prescription cannot be met and must also notify the nurse.”

“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 the interdisciplinary team addressed identified problems in the facility. This failure resulted in missed opportunities to improve the quality of care and denied patients their right to receive the minimum standard of medical care. Findings Included: On 08/06/2025 at 03:20 p.m., during review of the facility’s policies and procedures titled “Continuous Quality Improvement Program” (Policy 5-15-06), page 2 number 7 stated: “The facility will measure, analyze, and track quality indicators or other aspects of performance.” Including: Patient Safety: Review of product or equipment Between 07/28/2025 and 08/06/2025, interviews with three anonymous staff members disclosed that machine test failures are frequent in the facility and that management is aware of these recurring issues. Staff specifically identified negative pressure and optical detector/sensor test failures as the most common problems. On 08/06/2025, an interview with the Facility Administrator confirmed awareness of the ongoing equipment issues and stated the same most common problems. On 07/28/2025, an interview with a Bio-Medical staff member raised two key concerns: 1. Staff practices on the treatment floor - it was noted that, in most cases, machine test failures could not be replicated once the machines were removed from service. 2. Delayed reporting - staff reportedly do not inform Bio-Medical personnel of machine failures in real time, but instead wait until the end of the day to report the issues. On 08/06/2025, a review of the facility’s Facility Health Meeting (FHM) records found no documentation or discussion of these issues in the Quality Assessment and Performance Improvement (QAPI) meetings. There was no evidence that an investigation had been initiated to determine whether the source of the failures was related to the machines themselves or to staff setup procedures.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to ensure an adequate number of qualified and trained staff to meet the needs of the patients. This failure placed the patients at potential risk and denied their rights to a minimum standard of medical care. Findings Included: The Code of Maryland Regulations 10.05.04.06C (Dialysis Monitoring for Freestanding Kidney Dialysis Centers) states:... C. Dialysis Monitoring. (1) Staffing Ratio. (a) In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be: (i) A minimum of one staff member to three participants; and (ii) Sufficient to meet the needs of patients .... (c) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. 1. On 08/06/2025, at 01:30 p.m. during record review, the surveyor observed that the facility failed to meet the minimum patient ratio on the following dates: a. 07/11/2025 b. 07/14/2025 c. 07/16/2025 d. 07/18/2025 e. 07/28/2025 f. 07/30/2025 2. Interviews with Staff Member #3 and the Clinical Coordinator confirmed that the facility is occasionally staffed at a 4:1 patient-to-staff ratio.”