Fmc Mayaguez

“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: 47384 Based on observations made in the treatment area on 03/05/2025, it was determined that the facility failed to monitor the environment to ensure its sanitation and reduce the potential transmission of infectious agents within and between units, due to the lack of adherence to “standard precautions”. Findings include: 1. Paramedics were observed not performing hand wash with soap and water upon entry to the unit and did not wear gloves during the handling of patients. 2. At the time of observing the entrance area and weighing area of the unit, no designated trash can was identified for the disposal of isolation gowns. 3. At the time of leaving the treatment area and during beginning the second shift it was observed that various patients did not perform a hand washing with soap and water or used hand sanitizer. 4. During the visual tour of the Isolation room a mop was observed inside the cube and the broom was observed directly on the floor in the isolation room.”

“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: 15884 Based on observational tour of the patient treatment area on 03/05/2025 from 9:00 AM till 1:10 PM, it was determined that the facility failed to ensure that the treatment environment is comfortable and free of areas that would pose danger to patients, staff, and the public. These deficient practices had the potential to affect 120 out of 120 patients receiving treatment at the facility. Findings include: 1. The following was observed during the initial observational tour on 03/05/2025 from 9:00 AM till 1:10 PM: a. Every floor tile, floor corners and wall skirts are in bad condition. All floor tiles of the hemodialysis treatment area were observed to be very worn, rough with black and rusty spots. The condition in which the floor (deteriorated) and wall skirts are, give the appearance that the floor is dirty and sticky. b. Deficiencies related to the bad condition of the floor of the treatment area were cited during a recertification survey conducted on 03/14/2023. When the facility was surveyed for the follow-up survey on 05/17/2023 they stated that they were going to remodel the treatment area and replace the floor. During the follow-up survey of 05/17/2023 facility show some evidence of the remodeling process that they were waiting to begin in summer of 2023. Facility receives a recertification survey on 06/06/2024 and it was identified during survey that the remodeling process was not carried out. A rational explanation of the reason why the facility did not proceed with the remodeling was not provided. Floors in bad condition promote moisture, dirt, sediment, or even pathogens or microorganisms from burrowing into the surfaces. Facility shows evidence that every two weeks provide maintenance to the floor areas, however the condition of the floor (rough, porous, dull, crumpling at the edges and with areas where the adhesive is loosened) even if they clean it require replacement to ensure proper cleaning and disinfection is performed. c. During the review of the Governing Body committee meeting minutes dated 02/24/2025,01/27/2025,11/25/2024,10/29/2024,09/30/2024, and 08/26/2024, reveled that facility discuss that they were going to replace the floor however there are no evidence of a formal project or details ( quotation, budget, timeline projection) when this work are given a go by. d. During the interview on 03/05/2025 at 3:35 PM with the Chief Technician (employee #1) explain that the facility administration plans to replace the unit floor, were in the process of selecting materials and floor tiles design. Documents that define the requirements for the construction project, resources, schedule, and budget were not provided.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 47384 Based on observations made in the treatment area on 03/05/2025, it was determined that the facility failed to ensure that the building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. Findings include: 1. During a visual inspection of the unit, the lower part of the couter was observed between the baseboard and the floor of the couter where the unit’s drains are located with moisture damage. It is noted that the wood in this area is frayed and shows black spots, which could refer to black mold. This was observed on all counter areas of the unit. 2. Plastic receptacle covers on units counters were observed chipped or broken by treatmen chairs head rest.”

“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 observations made in the treatment area on 03/05/2025, it was determined that the facility failed to implement and maintain a program to ensure that all equipment are maintained and operated in accordance with the manufacturer’s recommendations. Findings include: At the time of the survey, the patient transfer hoist was inoperable. The nursing staff reported that this hoist had been acquired recently and that it had been damaged several times since it was acquired.”

“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 observations made of the treatment area, during the first shift and second shift of 03/05/2025 from 8:30 AM through 3:30 PM, it was determined that the facility failed to maintain Life Safety measures that complies with NFPA 101 (Life Safety Code), NFPA 99 (Health Care Facilities Code), which could affect all patients receiving treatment and staff. Findings include: Penetrations were observed in the dividing wall of the dialysis treatment unit and the corridor leading to the technical area.”

“PR-RESPECT & DIGNITY CFR(s): 494.70(a)(1) The patient has the right to- (1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD This Standard is not met as evidenced by: 51637 Based on the receipt of a complaint via telephone from a patient on the third shift it was determined that the facility failed to make efforts to provide treatment on time, in accordance with a schedule that meets patient needs, whenever is possible. Findings include: 1.On March 07, 2025, at 2:50 PM a complaint was received via telephone from a patient on the third shift who receives treatment at station 10 Monday, Wednesday and Friday. He explains that on Wednesday 05, 2025 arrived at the dialysis center at 3:45 PM and was connected to the machine at 6:05 PM. The patient explains that he is his mother’s sole caregiver, and the schedule of timely connection and disconnection is of utmost importance to him. 2.On March 10, 2025, at 3:35 PM the POC and flowsheets of this patient were reviewed and revealed that the connection hour on the assignment is 4:40 PM. 3.The facility failed to give the patient a valid reason or explanation why their shift was late. 4.The facility failed to ensure that patients with specific situations can be accommodated, cared for or informed according to the availability of treatment machines.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 15884 Based on review of the treatment flowsheets on 03/05/2025 at 1:00 PM, it was identified that the facility failed to follow physicians’ orders in the blood flow (BFR) and dialysate flow rate (DFR) during the dialysis treatment and documented their intervention in the management of the patients BFR and DFR. This deficient practice is identified in 3 out of 11 records reviewed (RR #6, #9, and #10). Findings include: Upon review of the facility’s policy # 45284 Patient assessment and monitoring last update on 05/01/2023, on 03/06/2025 at 10:30 AM. Policy clearly stated that during dialysis; personnel in charge must ensure prescribed blood flow (BFR) and dialysate flow rate (DFR) follows physician prescription throughout the treatment. 2. RR#9 is a 57-year-old male patient admitted to the facility on 09/09/2017 with a diagnosis of End Stage Renal Disease and Hypertension. This patient’s hemodialysis treatment order dated 02/17/2025 establishes that this patient must receive treatment by a Tunneled Chest Venous Catheter with a BFR 350 and DFR 600. Review of hemodialysis flowsheet dated 02/17/2025, on 02/19/2025, on 02/21/2025, on 02/24/2025, on 02/26/2025 and on 02/28/2025 with the Clinical Manager (employee #2) on those days with a BFR of 400 and a DFR of 600. Facility Manager (employee #2), stated in an interview on 03/06/2025 at 11:00 AM that after reviewing the medical record that did not find a rationale documented for the change of the BFR and DFR on this case on those days. 3. The facility failed to ensure that the medical record includes pertinent information related to the patient’s individual dialysis treatment change on prescription and parameters administered were according with the physician order. 51637 4. RR#10 is a 49-year-old male patient admitted to the facility on 09/05/2023 with a diagnosis of End Stage Renal Disease and Type 2 Diabetes Mellitus. This patient’s hemodialysis treatment order dated 02/20/2025 establishes that this patient must receive treatment by a Tunneled Chest Venous Catheter until de AV Fistula is mature and safe to use it with a BFR 400 and DFR 800. Review of hemodialysis flowsheet dated 02/20/2025 with the Clinical Manager (employee #2) on those days with a BFR of 400 and a DFR of 580. Facility Manager (employee #2), stated in an interview on 03/06/2025 at 11:10 AM that after reviewing the medical record that did not find a rationale documented for the change of the BFR and DFR on this case on those days. 5. The facility failed to ensure that the medical record includes pertinent information related to the patient’s individual dialysis treatment change on prescription and parameters administered were according with the physician order. 20423 6. RR#6 is a 48-year-old female patient admitted to the facility on 02/13/2014 with a diagnosis of End Stage Renal Disease and Hypertension. This patient’s hemodialysis treatment order dated 03/01/2025 establishes that this patient must receive treatment by a Tunneled Chest Catheter with a BFR 400 and DFR 800 Manual. Review of hemodialysis flowsheet dated on 03/01/2025 with the Clinical Manager (employee #2), on this day a BFR of 350 from 6:02 Am till 9:03 AM without an expanation or justification to decrease the BFR wthout a physican notification and order. Facility Manager (employee #2), stated in an interview on 03/06/2025 at 11:25 AM that after reviewing the medical record that did not find a rationale documented for the change of the BFR on this case on those days.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 51637 Based on review of eleven (11) medical records review (R.R.) with the Facility Manager (employee #2), it was determined that facility failed to ensure that the medical records contain complete information related to reasons for not documenting the standing blood pressure post the hemodialysis treatment. This deficient practice is identified in 3 out of 11 medical records reviewed. (#6, #8,and #10). Findings include: Upon review of the facility’s policy # 45284 Title: 45284 Patient assessment and monitoring last update on 05/01/2023, on 03/06/2025 at 11:50 AM. Policy clearly stated on the procedures that the register nurse who evaluates the patient must document the blood pressure after each treatment. 2. RR #8 is a 60-year-old male patient admitted to the facility on 11/01/2024 with a diagnosis of End Stage Renal Disease and Nephrotic syndrome. a. During the record review performed on 03/05/2025 at 2:20 PM it was found that during patient hemodialysis treatment flow sheets dated 02/19/2025 and 02/28/2025 the standing blood pressure post treatment was not documented. 3. RR #10 is a 49-year-old male patient admitted to the facility on 09/05/2023 with a diagnosis of End Stage Renal Disease and Type 2 Diabetes Mellitus. a. During the record review performed on 03/05/2025 at 2:50 PM it was found that during patient hemodialysis treatment flow sheets dated 02/20/2025 the standing blood pressure post treatment was not documented. The facility Manager (employee #2), stated in an interview on 03/06/2025 at 11:50 AM that after reviewing the medical record that did not find a rationale documented for standing blood pressure omitted. 4. The facility failed to ensure that the medical record includes pertinent information related to the patient’s individual dialysis treatment change. 20423 5. RR#6 is a 48-year-old female patient admitted to the facility on 02/13/2014 with a diagnosis of End Stage Renal Disease and Hypertension. a. During the record review performed on 03/05/2025 at 2:32 PM, it was found that during patient hemodialysis treatment flow sheets dated 02/27/2025 and 03/04/2025, the standing blood pressure post treatment was not documented. No evidence of the justification was documented. The nurse documented that the patient ambulate without assistance. The facility Manager (employee #2), stated in an interview on 03/06/2025 at 12:00 PM that after reviewing the medical record that did not find a rationale documented for standing blood pressure omitted. 6. The facility failed to ensure that the medical record includes pertinent information related to the patient’s individual dialysis treatment change.”

“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 on an Emergency Preparedness Program (EPP) survey performed on 05/06/2024 at 1:30 PM through 2:30 PM, 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 s disaster or emergency situation. Findings include: During the review of the facilities Emergency Preparedness Program with the Clinical Manager Secretary 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 including Health Care Coalition as required under §494.62(a)(4) of the Emergency Preparedness.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 47384 Based on Emergency Preparedness Program (EPP) survey performed on 05/06/2024 at 1:30 PM through 2:30 PM, to evaluate emergency preparedness requirements, it was determined that the facility failed to have written process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. Findings include: During the review of the facilities Emergency Preparedness Program with Clinical Manager Secretary it was noted that the EP failed to have written process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available.”

“Methods for Sharing Information CFR(s): §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.542(c)(4)-(6), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (4) A method for sharing information and medical documentation for patients under the [facility’s] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility’s] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI’s care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). This Standard is not met as evidenced by: 47384 Based on an Emergency Preparedness Program (EPP) survey and document review performed on 05/06/2024 at 1:30 PM through 2:30 PM, to evaluate emergency preparedness requirements, it was determined that the facility failed to provide a method for sharing information and medical documentation for patients under the hospice’s care, as necessary, with other health care providers to maintain the continuity of care. Findings include: During the review of the facilities Emergency Preparedness Program with Service Clinical Manager Secretary it was noted that the facility failed provide a written method for sharing information and medical documentation for patients under the hospice’s care, as necessary, with other health care providers to maintain the continuity of care as required under §494.62(c)(4)-(6).”

“Information on Occupancy/Needs CFR(s): §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.542(c)(7), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (7) [(5) or (6)] A means of providing information about the [facility’s] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC’s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice’s inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This Standard is not met as evidenced by: 47384 Based upon an Emergency Preparedness Program (EPP) survey and document review performed on 05/06/2024 at 1:30 PM through 2:30 PM, to evaluate emergency preparedness requirements, the facility failed to have written procedures of providing information about the facility’s occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. Findings include: During the review of the facilities Emergency Preparedness Program with the Clinical Manager Secretary it was noted that the facility failed to have written procedures of providing information about the facility’s occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.”

“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: 47632 Based on observation made of the treatment area, it was determined that the facility failed to monitor a sanitary environment to minimize the transmission of infectious agents between the units related “standard precautions”. Findings include: 1. During the observations made in the hemodialysis treatment area, the following was found: a. On 06/05/2024 at 9:48 AM the nurse (employee #6) has acrylic and bright orange color, according to Administrative Order No. 284 talks about keeping hands free of acrylic nails. b. On 06/05/2024 at 8:46 AM regular trash containers and biohazardous trash containers were observed between each hemodialysis treatment machine. Stations # 16, #17, #18, #19, #20, #21, #22, #23, #24, #25. The facility failed to ensure that regular and biohazardous trash containers touched the dialysis machine equipment every time they were opened and prevented the transmission of infectious agents. 15884 The following was observed when housekeeping personnel (employee 4) was mopping the floor in front of the nursing station and between station #9 and #10 on the second shift on 06/05/2024 at 11:55 AM: Housekeeping personnel (employee #4 ) is using a blue press wring bucket to rinse the mop before mopping the floor. The press wring bucket was observed in need of cleaning and with the metal areas of the wheels full of rust.”

“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: 15884 Based on review of policies and observations during patient disconnections procedures, it was determined that the facility failed to demonstrate that follows infection control precautions to prevent transmission of infections among hemodialysis patient’s related to lack of disinfection of privacy screens after being used during disconnection process for 5 out 5 observations made at stations #2,# 14,#16,#17 and #24. Findings include: Upon review of the facility’s policy #47806 Cleaning and Disinfection of Dialysis station last reviewed on 09/05/2023 on 06/05/2024 at 2:05 PM. Policy clearly stated that dialysis stations could become contaminated with blood or other body fluids during treatment. Policy also stated that all work surfaces should be cleaned and disinfected with 1:100 bleach solution before and after contact or working on them. Policy clearly stated that all supplies and non-disposable equipment used by personnel must be discarded or cleaned and disinfected with 1:100 bleach or EPA registered disinfectant when finish the procedure and before being removed from dialysis station area. 1.Hemodialysis nurse staff (employee #2) was observed on 06/05/2024 at 11:15 AM performing a disconnection process on a patient who had a left chest catheter that was located on station #14. Before beginning to perform disconnection Hemodialysis nurse staff (employee #2) move a privacy screen from the area where personnel store them to be used during the disconnection process. When finishes the disconnection process, she washes hands, folds the privacy screen and without disinfecting returns it to the area where personnel store them. 2. Hemodialysis nurse staff (employee #2) was observed on 06/05/2024 at 11:15 AM performing a connection process on a patient who had a Left chest catheter, that was located on station #2. When finishes the connection process she washes hands folds the privacy screen and without disinfecting return it to the area where personnel store them. 3. Facility Supervisor (employee #1), stated on interview on 06/05/2024 at 2:00 PM as per policy established that non disposable equipment used by personnel during the hemodialysis treatment connection and disconnection process must be discarded or cleaned and disinfected with 1:100 bleach or EPA registered disinfectant when finish the procedure and before being removed from dialysis station area. 4. The facility failed to promote and implement policies and procedures to prevent transmission of infections among hemodialysis patient’s. 47632 5. On 06/05/2024 at 8:46 AM it was observed that the screen, after being used by the nurse (employee #5) in the disconnection process with the patient from station #16, was not disinfected. 6. On 06/05/2024 at 10:09 AM it was observed that the screen, after being used by the nurse (employee #3) in the disconnection process with the patient at station #24, was not disinfected. 7. On 06/05/2024 at 10:09 AM it was observed that the screen, after being used by the nurse (employee #5) in the disconnection with the patient at station #17, was not disinfected.”

“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: 47384 Based on documents reviewed performed on 05/05/2024 through05/06/2024 with the Clinical Unit Supervisor (employee #1), it was determined that the facility failed to maintain a safe, functional, and comfortable treatment environment. Findings include: 1. The facility failed maintain an effective pest control program so that the facility is free of pests. a) A roach was found on drawer of counter inside the unit. b) Apparent rodent dropping was found on drawer of counter inside the unit.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 47632 Based on observation made of the treatment area, it was determined that the facility failed to monitor the furnished and maintained to ensure the safety of the patients. Findings include: 1. During the observations made in the isolation area, the following was found: a. On 06/05/2024 at 9:01 AM it was observed in the stained acoustic insulation room. b. On 06/05/2024 at 9:01 AM stained acoustic insulation and dusty floor were observed in the bathroom. c. On 06/05/2024 at 9:01AM the floor of the isolation room was observed stained . d. On 06/05/2024 at 9:01 AM the emergency light was dim. 2. During the observations made in the hemodialysis treatment area, the following was found: a. On 06/05/2024 at 9:27 AM a broken lens was observed on the counter behind stations #6 and #22. b. On 06/05/2024 at 9:36 AM the dirty sink was observed with a dark stain in the drain.”

“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 records reviewed of preventive maintenance (PM) logs of hemodialysis machines (HD) for the past 12 months, fifteen (15) out of thirty-three (33) were reviewed and noted deficiencies in the PM recorded hours. Findings include: During the review of the preventive maintenance documentation for the dialysis machines, it was observed that the clock hours did not have correct number sequence of machine clock hours. In instances the recorded hours exceeded those of previous months. Bad practice can alter the preventive maintenance cycle indicated by the manufacturer. Deficiencies in recorded hours were identified in the following machines: 9TOS244935 9TOS244946 9TOS244973 9TOS244982 9TOS244983 9TOS244990 9TOS244998 9TOS244999 9TOS245002 9TOS245010 9TOS245038 9TOS245048 9TOS245079 9TOS245088 9TOS245097”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 15884 Based on the observational tour and review of policies and procedures, and interview with facility nursing supervisor (employee #1), it was determined that the facility failed to ensure that patients receive treatment in a manner that allows staff to have full view of patient’s access sites for the first shift on 06/05/2024 from 8:30 AM thru 1:10 PM at patient’s stations #2 #17, and #22 ). This deficient practice affects 3 out of 21 patients observed receiving treatment. Findings include: 1. During observations of the hemodialysis treatment area on 06/05/2024 from 8:30 AM thru 1:10 PM the following was observed: Upon review of the facility’s policy # 5.04 Intradialytic Treatment Monitoring last update on 05/16/2022, on 02/22/2023 at 3:00 PM. Policy clearly stated that patients must be in view of staff during hemodialysis treatment to ensure patient safety. This policy stated that each patient, including his/her face, vascular access site and bloodline connections, must be able to be seen by staff members throughout the dialysis treatment. a. Patient located on station #2 was observed with line connections located on left arm fistula covered with blankets while receiving treatment. b. Patient located on station #17 was observed with line connections located on left chest catheter covered with blankets while receiving treatment. c. Patient located on station #22 was observed with line connections located on left arm arteriovenous fistula vascular access covered with blankets while receiving treatment. 2. Facility nursing supervisor (employee #1), stated on interview on 06/05/2024 at 1:17 PM as per policy established that if nursing identifies that vascular access and line connections are not visible, they must request to their patient to uncover the vascular access. He stated that if patients had covered access sites and line connections this provides an opportunity for accidental dislodgement or a line disconnection to go undetected. He stated that policy established indicates that nursing personnel must always educate and explain access visible at all times during the treatment. 3. The facility failed to promote policies and procedures that establish that access sites are to be left uncovered to allow complete visibility by the nursing staff, during hemodialysis treatment.”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 15884 Based on the observational tour and interview with facility nursing supervisor (employee #1), it was determined that the facility failed to promote that privacy in all aspects of treatment is maintained. This deficient practice affects 1 out of 21 patients (P) observed receiving treatment (P#2). Findings include: 1. P #2 is a 78-year-old female admitted to the facility on 12/04/2013 with a diagnosis of End Stage Renal Disease. This patient has both lower limbs amputated. It was observed on 06/05/2024 at 11:20 AM when patient came transported with 2 medical ambulance technician personnel that when transfer the patient from the stretcher to the hemodialysis chair, they were not careful to maintain the privacy of intimate genital areas of the patient. This patient is dressed in a printed gown and did not have a sheet covering her intimate genital areas. Transferring procedure is performed on hemodialysis station #2 and in front of this station there is located a male patient on station #14 who was watching right in front of station #2. 2. Nursing supervisor (employee #1) was interviewed on 06/05/2024 at 11:50 AM and he was asked in relation to the transferring procedure of patient located on station #2. He stated that nursing personnel assigned to oversee this station is responsible to be sure that during transferring procedure intimacy and privacy of patient is maintained specially in those cases were patients had an outfit that could move during transferring procedures.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 17959 Based on interview, policies, and procedure reviewed, and twelve records reviewed (RR), it was determined that the facility failed to monitor and document the patients’ blood pressure (B/P) and document nurse action when patient present hypotension and/or hypertension during dialysis treatment for 2 of 12 record review (R.R. #6 and #7). Findings include: 1. R.R #6 is an 86-year-old female patient admitted to the facility on 10/17/2023 with a diagnosis of End Stage Renal Disease (ESRD). During the record review performed on 06/06/2024 at 1:20 PM, it was found that this patient had hemodialysis order dated 05/09/2024 to receive hemodialysis treatment three times a week for 4 hours by CV Catheter -Tunneled with a BFR of 300 and DFR of 700, Dialyzer Optiflux 160 NRe. Patient Dry weight (EDW) 44.5 kilogram (Kg). During review of the most 6 recent treatment sheets on 06/06/2024 at 1:20 PM, it was identified that: a. On 06/04/2024 at 16:01 AM, the hemodialysis machine did not register the blood pressure at 30 minutes according to the policy and procedure. 2. R.R #7 is a 42-year-old male patient admitted to the facility on 02/10/2024 per transient and decided stay for admission. Diagnosis of End Stage Renal Disease (ESRD). During the record review performed on 06/06/2024 at 11:250 AM, it was found that this patient had hemodialysis order dated 04/10/2024 to receive hemodialysis treatment three times a week for 4 hours by CV Catheter -Tunneled with a BFR of 400 and DFR of 800, Dialyzer Optiflux 180 NRe. Patient Dry weight (EDW) 102 kilogram (Kg). During review of the most 6 recent treatment sheets on 06/06/2024 at 1:20 PM, it was identified that: a. On 05/27/2024 the patient only received three hours and 30 minutes of treatment, however no evidence from the nurse documented the reason to shorten treatment. b. On 05/29/2024 patient BFR was maintained at 500 per eight times not according with the physician orders of 400. c. On 05/31/2024 the patient DFR did not register on the hemodialysis machine when the patient initiated the hemodialysis treatment at 5:28 PM.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 15884 Based on the observational tour and interview with facility environment technician (employee #8), it was determined that the facility failed to monitor the assessment and improvement of care in the facility. Findings include: 1. During the review of the quality assessment and improvement QAPI program activities on 06/06/ 2024 at 1:30 PM for the natural year 2023 through the months of January, February, March and April of 2024, it was identified that facility planned to perform a remodeling of facility and water treatment area which was going to begin on the month of August 2023. This remodeling process was part of a plan of correction activity that facility notify that was going to take place to correct deficiencies cited on a recertification survey what was carried out on prior recertification on 03/14/2023. 2. Facility environment technician (employee #8) stated that based on deficiencies cited on recertification survey of 03/14/2024 where facility failed to maintain physical environment free from potential risks to health and safety all patients due to physical environment in need of remodeling facility planned to begin on the month of August 2023. He stated that facility fix some areas to mitigate physical environment poor condition until beginning with the remodeling in August 2023. However no detailed information and explanation with evidence was provided by (employee #8), of the reason why the remodeling was not started on the projected time. 3. Review of QAPI committee meeting documentation for the months of August, September, October, November, December of natural year 2023 did not evidence any discussion or explanation of the reasons why the remodeling that must began in on August, 2023 had a delay. 4. Review of QAPI committee meeting documentation for the months of January, February, March, April and May of natural year 2023 did not evidence any discussion or explanation of the reasons why the remodeling that must begin in August, 2023 had a delay. 5. Facility QAPI program failed to track, follow the course and monitor physical environment aspects of performance that facility must adopt to correct situations that were previously identified and that had the potential to affect patient outcomes and to identify opportunities for improving care.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 15884 Based on the observational tour and interview with facility environment technician (employee #8), it was determined that the facility failed to monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. Findings include: 1. During the review of the quality assessment and improvement QAPI program activities on 06/06/ 2024 at 1:30 PM for the natural year 2023 through the months of January, February, March and April of 2024, it was identified that facility planned to perform a remodeling of facility and water treatment area which was going to begin on the month of August 2023. This remodeling process was part of a plan of correction activity that facility notify that was going to take place to correct deficiencies cited on a recertification survey what was carried out on 03/14/2023. 2. Facility environment technician (employee #8) stated that based on deficiencies cited on recertification survey of 03/14/2024 were facility failed to maintain physical environment free from potential risks to health and safety all patients due to physical environment in need of remodeling facility planned to begin on the month of August 2023. He stated that facility fix some areas to mitigate physical environment poor condition until beginning with the remodeling in August 2023. However no detailed information and explanation with evidence was provided by (employee #8), of the reason why the remodeling was not started on the projected time. 3. Review of QAPI committee meeting documentation for the months of August, September, October, November, December of natural year 2023 did not evidence any discussion or explanation of the reasons why the remodeling that must begin in August 2023 had a delay. 4. Review of QAPI committee meeting documentation for the months of January, February, March, April and May of natural year 2023 did not evidence any discussion or explanation of the reasons why the remodeling that must begin in August 2023 had a delay. 5. Quality assessment and improvement QAPI program activities perform by facility on 06/06/ 2024 at 1:30 PM for the natural year 2023 through the months of January, February, March and April of 2024, did not evidence documentation of the status and reasons why the remodeling that must begin in August, 2023 had a delay. 6. Facility QAPI program failed to follow the implementation of improvements plans, to follow all aspects that assure the success of the plan.”

“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: 15884 Based on the observational tour and interview with facility environment technician (employee #8), it was determined that the facility failed to set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that could affect clinical outcomes or patient safety. Findings include: 1. During the review of the quality assessment and improvement QAPI program activities on 06/06/ 2024 at 1:30 PM for the natural year 2023 through the months of January, February, March and April of 2024, it was identified that facility planned to perform a remodeling of facility and water treatment area which was going to begin on the month of August 2023. This remodeling process was part of a plan of correction activity that facility notify that was going to take place to correct deficiencies cited on a recertification survey what was carried out on 03/14/2023. 2. Facility environment technician stated that based on deficiencies cited on recertification survey of 03/14/2023 were facility failed to maintain physical environment free from potential risks to health and safety all patients due to physical environment in need of remodeling facility planned to begin on the month of August 2023. He stated that facility fix some areas to mitigate physical environment poor condition until beginning with the remodeling in August 2023. However no detailed information and explanation with evidence was provided by employee #8, of the reason why the remodeling was not started on the projected time. 3. Review of QAPI committee meeting documentation for the months of August, September, October, November, December of natural year 2023did not evidence any discussion or explanation of the reasons why the remodeling that must began in August 2023 had a delay. 4. Review of QAPI committee meeting documentation for the months of January, February, March, April and May of natural year 2023 did not evidence any discussion or explanation of the reasons why the remodeling that must began in August 2023 had a delay. 5. Quality assessment and improvement QAPI program activities perform by facility on 06/06/ 2024 at 1:30 PM for the natural year 2023 through the months of January, February, March and April of 2024, did not evidence documentation of the status and reasons why the remodeling that must begin in August 2023 had a delay. 6. Facility QAPI program failed to promote improvement in all areas needing improvement and to prioritize these, ranking those which have potential to affect patient health and safety.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 17959 Based on thirty seven credentials records (CR) reviewed, it was determined that the facility failed to ensure that the staff meet the personnel qualifications evidence by annual evaluation not perform from more than a year for 11 out of 37 credential records reviewed (C.R. #4, #5, #6, #9, #11, #20, #22, #26, #27, #28 and #29 ). Findings include: 1. Review of the credential files on 06/05/2024 at 2:05 PM and the following was provided: a. C.F. #4, #5, #6, #9, #11, #20 provided evidence that no annual evaluation was performed until 03/2014 and 03/2019, no evidence of annual evaluation updated. b. C.F. #22 no evidence of Job Description. c. C.F. #6 did not provide evidence ’’ buena conducta ’’ good conduct. d. C.F. #26 did not provide evidence of annual health certification. The last health certification was performed on 11/29/2022. e. C.F. #27 did not provided evidence ’’ nombramiento “ Apponintment. f. C.F. #28 and #29 did not provide evidence competency. g. C.F. #28 and #29 did not provided evidence Covid Vaccine. 2. The facility failed to ensure that all staff meet the personnel qualifications evidence by annual evaluation, Job description, good conduct, annual health certification, appointment, competency and Covid Vaccine.”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 47632 Based on review of the infection control policies and procedures manual on 06/05/2024 at 2:13 PM with the Clinical Manager (employee #9), it was determined that the facility failed to ensure the periodic review and approval of a “patient care policies and procedures manual” for infection control of the facility. Findings include: 1. During reviwed of P&Ps manual, and observations with the clinical manager (employee#9), the following was found: a. On 06/05/2024 at 2:13 PM, it was observed that the infection control manual had not been updated on August 2023.”