Atlantis Fajardo

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 47384 Based upon an Emergency Preparedness Program (EPP) survey performed on 02/14/2024 at 8:30 AM through 4:00 AM, to evaluate emergency preparedness requirements, it was determined that the facility failed to include a process for cooperation and collaboration with local, tribal, regional, State and Federal emergency preparedness officials’ effort to maintain an integrated response during disasters or emergency situation. Findings include: During the review of the facilities Emergency Preparedness Program with the Acting Manager (employee #1) on 02/14/2024 at 9:30 AM it was noted that the facility failed to include a process for cooperation and collaboration with local, tribal, regional, State and Federal emergency preparedness officials as required.”

“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: 17959 Based on observations made of the treatment area, isolation room, review of policies and procedures, staff interview and credential files reviewed, it was determined that the facility failed to monitor the environment to ensure that it is sanitary to reduce possible transmission of infectious agents related to the treatment area, mold on patient treatment chairs, dust on different areas of the acoustics, dust and dirty patient scale and patient’s bags located directly on the floor which can affect 79 out of 79 patients receiving treatment at the facility. Findings include: 1. The following was observed on 02/13/2024 from 9:30 AM till 11:55 AM: a. During the observation performed on 02/13/2024 at 10:30 AM on different areas of the treatment area it was observed accumulation of black dust on the acoustics and air conditioning plastic vents on patient stations #13 through #19. b. On 02/13/2024 at 9:30 AM a deteriorated patient scale with dust, dirty and mold was observed. c. On 02/13/2024 from 9:30 AM till 11:55 AM, it was observed mold on the footrest of the patient treatment chairs located on the stations #7, #10, #11, #12, #13, #22, #23 and #24. d. On 02/13/2024 on second shift during connection it was observed at 11:10 AM through 11:30 AM on stations #6, #9, #11, #20, when the patients enter the treatment unit they place their personnel bags on the floor when performing the hand washing, then go to the hemodialysis treatment station with the bags, suitcase and old personal bags and then place them over the treatment chair hand rest or directly on the floor and place small bags on the treatment chair hand rest. This practice constitutes a high infection risk and cross contamination. The facility’s Vice President Clinical Operations-VPO (employee #5) stated in an interview that the facility has a designated area for the patients’ personnel bags.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 47384 Based on a ESRD Core recertification survey, observations, interview with the Regional Technician (employee #2), and review of policies/procedures on 02/14/24 from 9:00 AM thru 4:00PM, it was determined that the facility failed to have sinks plumbed with both hot and cold water; if the flow of water is started through motion detection, adjustments to the system must assure that warm water is available to encourage staff to wash their hands. This could affect all patients and employees. Findings include: 6 of 6 hand wash stations inside the unit were tested and no hot water came out of faucet, the motion sensor did not allow suficient time for water to heat.”

“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: 47384 Based on a ESRD Core recertification survey, observations, interview with the Regional Technician (employee #2), and review of policies/procedures on 02/14/24 from 9:00 AM thru 4:00PM, it was determined that the facility failed to have clean areas clearly separated from contaminated areas. Findings include: During the observation of the dialysis unit, a hand washing station was seen next to a disposal station. This can make it easier for material to be discarded to contaminate the clean area and cause cross-contamination.”

“BACT OF H20-MAXIMUM & ACTION LEVELS CFR(s): 494.40(a) 4.1.2 Bacteriology of water: max & action levels Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for reuse, shall contain a total viable microbial count lower than 200 CFU/mL and an endotoxin concentration lower than 2 EU/mL The action level for the total viable microbial count in the product water shall be 50 CFU/mL, and the action level for the endotoxin concentration shall be 1 EU/mL. If those action levels are observed in the product water, corrective measures shall promptly be taken to reduce the levels. This Standard is not met as evidenced by: 47384 Based on a ESRD Core recertification survey, observations, interview with the Regional Technician (employee #2), and review of policies/procedures for water traetment on 02/14/24 from 9:00 AM thru 4:00PM, it was determined that the facility failed to mantain a recommended maximum concentration bacteria in the water used to prepare dialysate. Findings include: During the review of documents from the water treatment area, it was observed that for the month of February an endotoxin metric was identified that is not in accordance with the established parameters.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 47384 Based on a ESRD Core recertification survey, observations, interview with the Regional Technician (employee #2), and review of policies/procedures on 02/14/24 at 1:45 PM, it was determined that the facility failed to cunduct a correct and acurate chlorine testing procedure. Findings include: During the observation of chlorine testing procedure performed by (RN #3) it was observed that the nurse came into contact with a marking attached to the water intake when taking the sample. This may allow dust particles and other materials to come into contact with the sample and affect the test. It was also observed that the technique of moving the strip to take a reading was not adequate and may also affect the reading.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 15884 Based on a ESRD Core recertification survey, observations, interview with the interim clinical manager (employee #2), and review of policies/procedures, it was determined that the facility failed to ensure that 1 out of 4 nursing personnel (RN#3) follow policies and procedures when checking pH of water used for dialysis, before starting the treatment on a patient. Findings include: Review on 02/14/2024 at 2:30 PM of the facility’s policy #15.43 Dialysate pH Testing and Conductivity last update on 03/31/2017and on 03/15/2023. Policy clearly stated on the procedures that to test pH personnel must fill the Osmometer’s “ Plunger “ with dialysate from the machine’s sleeve and dip the test strip to be tested and move back and forth for one second. That remove the strip and shake the excess liquid; and after 10 seconds compare the strip to the color chart on the bottle. 1.The following was observed while personnel were preparing hemodialysis machines for the second shift on 02/13/2024 from 10:00 AM till 11:55 AM: a. The register nurse (RN#3) is observed, performing the pH and conductivity test at the hemodialysis machine located at station #25. To perform the pH test on this machine, RN#3 pour the dialysate directly from the machine dialysate sleeve to the PH test strip. She let the pH test strip to absorb the liquid and then made the lecture of pH results. b. Facility assistant clinical manager (employee #2), stated in an interview on 02/14/2024 at 3:00 PM that nursing personnel must perform pH test accordingly with policies and procedures to ensure that solutions correspond to physician’s prescribed dialysate.”

“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: 47384 Based on a ESRD Core recertification survey, observations, interview with the Regional Technician (employee #2), and review of policies/procedures on 02/14/24 from 9:00 AM thru 4:00PM, it was determined that the facility failed to maintain a program to ensure that all equipment are maintained and operated in accordance with the manufacturer’s recommendations. Findings include: 1. 13 of 27 in dialysis unit were observed with rust in some of their components. When identified a closer observation was performed and dust and scum was also noticed in core components of the dialysis machines. 2. 1 of 3 UV lights were found inoperative. It was also observed that the sticky sheet had many flying insects. 3. Excessive dust was found in the counters behind the patients’ chairs. 4. Signs of humidity and fungi were observed on the acoustic tiles near the air conditioning system outlet vents (20 of 30). 5. Exposure to moisture was observed on the gypsum board wall caused by water contact under the sink located next to the patient bathroom of the unit. 6. Softener tank was observed dripping at the top in the seal area.”

“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: 47384 Based on a ESRD Core recertification survey, observations, interview with the Regional Technician (employee #2), and review of policies/procedures on 02/14/24 from 9:00 AM thru 4:00 PM, it was determined that the facility failed to comply with related provisions of the safety. This could affect all patients and employees. Findings include: 1. During observation tourof the unit a medical screen, trash can and a sitting stool were observed blocking a fire stinguisher next to station #18. 2. During observation tour of the unit three walkers were observed obstructing the free passage to the emergency exit that leads to the waiting area. 3. Patients were observed on a stretcher in the waiting area to be admitted to the unit, the paramedics were in front of the emergency exits of the administrative area which would make it difficult for free passage out of the building.”