Davita Pikesville Dialysis

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 44367 Based on the overall findings of the survey, the facility’s Governing Body, Administration and the Medical Director failed to meet the Condition for Coverage (CfC: 494.60) for Physical Environment as evidenced by: 1) failure to ensure machines safety checks were conducted in compliance with the manufacturer’s recommendation and its own policy; and 2) failure to ensure that patients received their dialysis treatment in a clinical treatment area that is comfortable and at an acceptable temperature. This failure placed all patients at an increased risk for serious harm and/or injury. Findings include: 1. Cross reference to Physical Environment - Equipment Maintenance (V0403) 2. Cross reference to Physical Environment - Comfortable Temperature (V0405)”

“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: 44367 Based on observations, record reviews, and staff interviews, the facility’s governing body failed to ensure that the clinical staff conducted safety checks of the dialysis machines in accordance with the manufacturer’s instructions and its own policy. This failure placed patients at risk for serious harm or death. Staff: Charge Nurse #1, Staff #1 and Staff #2 Findings include: Review on 06/25/2025 at 10:40 a.m. of the Fresenius 2008T Machine Operator’s Manual, page 74 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, do not use it for treatment. Remove the machine from service and have it inspected by a qualified technician to correct the problem.” Review on 06/25/2025 at 10:40 a.m. of the facility’s policy entitled, “Priming A Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Nipro or Combiset Blood Lines for Subsequent Treatment Shifts” determined that page 7 stated, “If the dialysis delivery system fails any of the test and the cause cannot be corrected or if it fails subsequent tests the system should not be used for treatment.” On 06/25/2025 at 10:28 a.m. the surveyor observed that machine #23 located at station #18 failed the safety tests two consecutive times. The surveyor asked the Charge Nurse what the policy regarding machine testing was. The Charge Nurse #1 informed the surveyor that the machine can be tested three times and that machine #23 would be tested for a third time. At 10:30 a.m., the surveyor observed Charge Nurse #1 test machine #23 for a third time. The patient was sitting in the chair of station #18 waiting to receive treatment. At 10:33 a.m., the Facility Administrator (FA) and the Clinical Specialist were informed of the findings and the safety issue. Immediately after the surveyor informed the FA of the findings, the FA instructed the assigned patient care technician to pull machine #23 out of service. At 10:50 a.m. the surveyor asked Staff #1 and Staff #2 what was the policy regarding machine testing and both informed the surveyor that the machine can be tested three times before being removed from service. During an interview with the Clinical Specialist, the surveyor was informed that the staff were “trained to test three times on the new machines.” The surveyor asked if he/she provided education since the facility received the new machine and the Clinical Specialist stated “no.” The facility’s failure to conduct the required safety testing according to manufacturer instructions placed the facility ’ s patients at risk of serious injury, serious harm, and possible death. Due to the seriousness of the concern that the facility staff failed to operate dialysis machines according to manufacturer’s recommendations, an immediate jeopardy (IJ #2) statement was issued to the facility at 12:15 p.m. on 06/25/2025, by the Office of Health Care Quality (OHCQ). On 06/26/2025 at 11:30 a.m., the OHCQ survey team verified that the facility implemented an acceptable IJ removal plan, which included the following actions: 1. The facility held in-services to educate all teammates present in the facility. Education of all remaining teammates to be completed upon their return to work and prior to setting up machines. 2. The facility performed observational audits for every machine being used on each shift to verify 1) set up and safety testing is performed per policy and 2) any machine failing two (2) consecutive safety testing is removed from service. 3. This process to continue until one hundred percent (100%) compliance is achieved with following manufacturer instructions for setting up and safety testing of machines for two (2) consecutive weeks. Once achieved, the audits are to continue every shift once weekly for two (2) weeks then every shift monthly for two (2) months. 4. All instances of non-compliance to be addressed by the auditor with real-time coaching and/or following the facility disciplinary process up to and including termination when warranted. 5. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this IJ removal plan.”

“PE-COMFORTABLE TEMPERATURE CFR(s): 494.60(c)(2) The dialysis facility must: (i) Maintain a comfortable temperature within the facility; and (ii) Make reasonable accommodations for the patients who are not comfortable at this temperature. This Standard is not met as evidenced by: 44367 Based on observations, record reviews, and staff interviews, the facility’s governing body failed to ensure that the environment of clinical treatment was comfortable and at a suitable temperature for patients while they were receiving dialysis treatment. This failure placed patients at risk for serious harm due to exposure to high temperatures, which are associated with elevated risk for both mortality and health care utilization among hemodialysis patients. Findings include: On 06/24/2025 at 03:30 p.m., review of the facility’s policy entitled, “Physical Environment” page 1 stated, “The dialysis facility will take reasonable steps to: Maintain a comfortable temperature within the facility.” On 06/24/2025 at 03:15 p.m., during observations of the treatment floor, the surveyor noted that the temperature on the Clinical treatment floor was: “ 86 degrees Fahrenheit according to the thermometer between stations #19 and #20. “ 82.4 degrees Fahrenheit according to the thermometer between stations #2 and #3. “ Noted by the surveyor to be elevated compared to the office area of the clinic. There was no air circulating throughout the clinical treatment area, causing the remaining staff to visibly have sweat running down their faces and some with visible wet areas on thier clothing. The temperatures above were observed without the machines running. It was known that the temperatures would potentially increase with the machines running. At 03:16 p.m., three staff members were interviewed and all three informed the surveyor that the “air” had not worked for over a week. During an interview with the Facility Administrator on 06/24/2025, the “air” stopped working yesterday on 06/23/2025, but arrangements for patients have not been made. The FA corroborated that the air condition unit was not working in the clinical treatment area and that the facility did not make arrangements for patients to receive dialysis at the facility’s back up dialysis facility. The facility’s failure to ensure that the physical environment ’ s temperature (86 and 84.2-degrees Fahrenheit) of the clinical treatment area was at a comfortable range placed the facility ’ s patients at risk of serious injury and/or serious harm. An immediate jeopardy (IJ #1) statement was issued to the facility at 04:55 p.m. on 06/24/2025, by the Office of Health Care Quality (OHCQ). On 06/26/2025 at 11:30 a.m., the OHCQ survey team verified that the facility implemented an acceptable IJ removal plan, which included the following actions: 1. Four temporary spot coolers were set up and used to lower the temperature on the treatment floor until the unit became fully functional. Spot coolers to remain at the clinic as backups to ensure continuous patient care. 2. Facility Services reported to the Facility Administrator that the air conditioning system was repaired and operational. 3. A contingency plan for patients to dialyze in alternate facilities was developed in the event neither of the above plans results in acceptable ambient temperatures within the facility. 4. In-services held to educate all teammates present in the facility. Education of all remaining teammates to be completed upon their return to work. 5. Audits to be performed twice daily to record both temperature readings of the two wall thermostats located on the treatment floor and documented using the facility room temperature log. Audits will be performed first thing in the a.m. and midday. The facility to continue to perform twice daily audits for the next four (4) weeks, then weekly for the next two (2) months. 6. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this IJ removal plan.”