Fmc Aguadilla

“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 observations made in the treatment area on 02/11/2025, it was determined that the facility failed to ensure to maintain sufficient space to provide necessary services and prevent cross-contamination. Findings include: During the observations made in the treatment area, the following was observed: 1. On 02/11/2025 at 9:19 AM, the side tables of the chairs were observed stuck at stations #7 and #8 during dialysis treatment. 2. On 02/11/2025 at 9:23 AM, the trash cans were observed touching parts of the dialysis machine at stations #2, #3, #8, # 9, #10, #11, #16, #17, #20 and #21 during dialysis treatment.”

“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 observation tour in the patient treatment area during the first and second shift, on 02/11/2025 from 8:30 AM to 3:30 PM, it was determined that the facility failed to ensure that the medical equipment is safe, functional, and comfortable for the patient and staff while the patients are receiving treatments. The facility failed to ensure it is designed, constructed, equipped, and provide dialysis patients and staff in a safe, functional, and comfortable treatment environment . This can affect 43 out of 43 patients recieving treatment during the first and second shift. Findings include: During the observaion performed the folowing was observed: A metal ramp plate was observed attached to the scale in the patient weighing area, the plate was not screwed or secured in any way to the scale. This can be considered a tripping hazard or can cause the wheelchair or treatment chair to not be stable when placing on the scale.”

“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 of the treatment area, on 02/11/2025, it was determined that the facility failed to monitor the physical environment to ensure that it is maintained to ensure the safety of the patients, the staff and the public. Findings include: During observational survey performed on treatment area it was found: 1. Water damage was found on the bottom wooden part of the counter were the therapy supply station is located. This was observed behind stations #4 and #5 and behind stations #22 and #23. All counters should be verified for hidden damage. 47632 During observations made in the isolation room on 02/11/2025, the following was observed: 2. On 02/11/2025 at 9:59 AM, scale was observed on the sink faucet. 3. On 02/11/2025 at 10:10 AM, observed dark stain in sink drain During the observations made in the medicine room on 02/11/2025 through 02/13/2025, the following was observed: 4. On 02/13/2025 at 9:22 AM, it was observed that one of the cabinet doors where medications were stored did not have a lock. 5. On 02/13/2025 at 9:40 AM, a hole was observed in the wall.”

“PE-PT CARE ENVIRONMENT-SUFFICIENT SPACE CFR(s): 494.60(c)(1) The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. This Standard is not met as evidenced by: 47384 Based on observations made of the treatment area, on 02/11/2025, it was determined that the facility failed to mantain sufficient space to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. Findings include: During observational survey performed on treatment area it was found: Five stations (#2, #7, #8, #15 and #16) were observed with limited space. Station #2 is located too close to the glass wall (isolation room), clearance should be at least 3 feet from walls or partitions, Stations #7, #8, #15 and #16 were observed with fold down side tables touching, this would prevent the handling of the patient in a situation where the staff needs to care for the patient in an emergency situation as stated on Guidlines for Desing and Construction of Outpatient Facilities (FGI) 2.10-3.2.2 (2).”

“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 02/11/2024 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) and NFPA 99 (Health Care Facilities Code) provisions which could affect all patients receiving treatment and staff. Findings include: 1. Fire extinguisher was observed blocked by crash cart next to fire emergency exit leading to staff parking lot. 2. Fire extinguisher and fire emergency exit leading to the patients parkng lot was observed blocked by computer table. 3. Soap dispenser was observed next to emergency pull station, pull station was found with soap residue on the closest part to the dispenser. This may cause the divice to become damaged or not work properly. 4. Exit discharge leading to the employee parking lot has a ramp which poses a safety risk for evacuation of patients in wheelchairs or treatment chairs. It does not comply with NFPA 101 7.2.5. 5. At the moment of the survey no written evidence that the four (4) fire doors in the facity had been inspected. After further observation, none of the fire doors or frame had the fire rating decal to validate fire rating. To assure that fire doors are working properly NFPA 80 (Standard for Fire Doors and Other Opening Protectives) section 5.2.1 mandates that fire doors should be inspected and tested at least once a year.”

“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 the observational tour of the patient’s treatment area during the first shift on 03/12/2024 at 8:30 AM to 1:00 PM, it was determinate that the facility failed to monitor the environment to ensure that it is sanitary to reduce possible transmission of infectious agents related to the isolation room, cleaning between shifts, correctly using trash containers and correctly using sinks to ensure proper infection control standards to avoid cross contamination. Findings include: 1. During observations of the patient’s treatment area on 03/12/2024 and 03/13/2024 from 8:30 AM till 1:00 PM the following was found with a nurse supervisor (employee #3): a. On 03/12/2023 at 9:45 AM walls located on the Exit side in front of station #16 were observed with spots and accumulation of black dust on borders of the walls. b. All the floor around the unit was observed dirty, porous, deteriorated material and dust. c. Five oxygen concentrated used for patients were observed near the sink located behind hemodialysis unit expose to received splash water when the personnel are washing hands. d. The storage door was observed dirty and with dust. e. The wall located behind handwashing in the isolation room was observed with water spots. f. The borders of the door located in the isolation room were observed dirty, black spots and black dust. g. Three plastic bottles of ‘Citruclean’’ was observed in the interior of the handwashing used to cleaning and disinfecting treatment chair and other equipment. h. At 11:40 AM the sink located in the contaminated area was observed with the presence of mold around the edge. Two small tanks were observed with preparation of water and Clorox dated 11/02/21 used to cleaning and disinfecting treatment chairs and other equipment. i. A regular trash can was observed near the handwashing located at the storage exit door; one of the plastic covers was broken. j. At 11:43 AM a deteriorated nursing counter was observed, the borders lacks Gibson boards material and evidence of dust. k. The Emergency tray located in front of the nurse counter was observed with dust on the exterior. l. At 11:44 AM on second shift patient put his bag directly on the floor then perform a hand washing and then cleaning vascular access located on left arm and drys, then he take his bag and go to the station #16 put his bag on the right side of the arm rest of the treatment chair and then place it directly on the floor.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 15884 Based on the observational tour of the patient’s treatment area during the first shift on 03/12/2024 at 8:30 AM to 1:20 PM, it was determinate that the facility failed to ensure that nursing personnel follows acceptable infection control procedures for patients during the connection jugular venous catheter. This deficient practice is identified in 1 out of 2 central venous catheter connection procedures observed. Findings include: 1. During the during the first shift on 03/12/2024 at 8:30 AM to 1:20 PM while observe central venous connection process the following was identified: a. Hemodialysis nurse (employee #11) was observed on 03/12/2024 at 11:29 AM performing a connection procedure on a right jugular vein of patient# 6 on station #20. Before beginning the procedure Hemodialysis nurse (employee #11) wash hands put clean gloves and proceed to prepare the working area to spread out the supplies. Employee #11 proceeds to remove old dressings, check the catheter site for signs of infection and discard old dressing. She scrubs the catheter hubs and puts a transparent new dressing on catheter site area and change hubs stopcocks. While she was applying the new dressing when took off the package where the dressing and stopcocks were wrapped it was observed that she keeps the wraps on her left hand instead of discarding used items. She washes hands, puts on a new pair of gloves, and proceeds to irrigate the catheter before connecting the port to the hemodialysis machine lines. After irrigating the catheter, she maintains the syringe used to irrigate the catheter on her left gloved hand and proceeds to manipulate lines with her right hand. Employee #11 is right-handed. While she was performing the irrigation of catheter and before connecting the catheter lumen to the lines it was observed that she maintains used (dirty items) on left hand at the same time manipulate sterile items with right hand. Facility failed to ensure that nursing personnel maintain aseptic techniques that can help medical surgical items from being contaminated. 17959 2. During the second shift on 03/12/2024 at 12:05 PM to 12:35 PM while observe venous connection process the following was identified: a. Hemodialysis nurse (employee #09) was observed on 03/12/2024 at 12:05 PM performing a connection procedure on a left forearm of patient #11 on station #03. Before beginning the procedure Hemodialysis nurse (employee #09) wash hands put clean gloves and proceed to prepare the working area to spread out the supplies. Employee #9 proceeds to remove old dressings, check the canalization site and discard old dressing. She scrubs the area three times and then puts a used dressings at the left side of the area but does not discard the used material. Then management the machine removed her gloves and cleaning her hands with hand sanitizer then put a pair of gloves immediately she touch her hair and removed the stethoscope localized around the neck and performed at patient assessment, then cleaning and disinfected the stethoscope put the used alcohol swaps in the cleaning area and with the same gloves cleaning and disinfected the access site and check the canalization site with the stethoscope and process to canalized the patient access. Then fixed the lines and initiated the hemodialysis treatment. During the canalization process the nurse (employee #9) failed to discard the used material on the garbage and she maintained the sterile materials and used materials in the same area. The nurse removed her gloves and cleaned her hands with hand sanitizer. The facility failed to ensure that nursing personnel maintain aseptic techniques that can help medical surgical items from being contaminated.”

“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, interview, and observations during patient connections 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 connection process for 2 out 2 observations made at stations #5 and #20. Findings include: Upon review of the facility’s policy #47806 Cleaning and Disinfection of Dialysis station last reviewed in 2022 on 03/13/2024 at 3:45 PM. Policy clearly stated that dialysis station could become contaminated with blood or other body fluids during treatment. The 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 #11) was observed on 03/12/2024 at 11:25 AM performing a connection process on a patient who had a Right Jugular catheter that was located on station #20. While she was performing the connection process, she used 2 privacy screens for the patient’s privacy. When nurse staff (employee #11) finishes the connection process she returns those 2 privacy screens to the area where personnel put them without cleaning and disinfection. 2.Hemodialysis nurse staff (employe #12) was observed on 03/12/2024 at 1:45 AM performing a connection process on a patient who had a Right Jugular catheter that was located on station #5. While he was performing the connection process, he used a privacy screen for patient’s privacy. When nurse staff (employee #12) finish the connection process he returns the privacy screen to the area where personnel put them without cleaning and disinfection. 3. Facility Manager (employee #3), stated on interview on 03/13/2024 at 3:50 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 patients’.”

“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’s treatment area during survey procedures on 03/12/2024 and 03/13/2024 from 8:30 AM through 4:30 PM, interview of patients and interview with physical environment regional officer (employee #1) and review of purchase documents it was determined that the facility failed to ensure that dialysis facility is equipped, to provide dialysis patients comfortable treatment environment for 7 out of 29 treatment chairs. Findings include: 1. The following was identified during survey procedures on 03/12/2024 and 03/13/2024 from 8:30 AM through 4:30 PM: a. Hemodialysis chairs located on station # 13 and #18 were observed with broken vinyl on chair arm rest and chair footrest. b. Hemodialysis chair located on station # 9 is observed with broken vinyl on chair footrest. c. Patient located on station #9 stated in an interview on 03/13/2024 at 9:30 AM that there are some chairs where she receives treatment had broken vinyl on chair arm rest and chair footrest. d. Patient located on station #10 stated in an interview on 03/13/2024 at 9:10 AM that there are some chairs where he receives treatment had broken vinyl on chair arm rest and chair footrest. e. Patient located on station #13 stated on interview on 03/13/2024 at 9:50 AM that there are some chairs where he receives treatment whose back of the chair cannot be reclined to accommodate the body more comfortably while receiving treatment because chair reclined system is broken or mal functioning. During interview on 03/12/2024 at 2:00 PM physical environment regional officer (employee #1) stated that facility had identified that some hendiadys chairs are in poor condition in need of change since the month of July 2023. He explains that on 07/28/2023 he made a purchase request for 5 new chairs in order to replace chairs in poor condition. He stated that he has been following up the purchase since 07/28/2023. He explains that vendor communicate by email with him on 01/24/2024, to inform that due to problems with manufacturer order will have a delay. Vendors communicate with him again by email on 02/12/2024 and inform that the purchase will be available on late April 2024. 17959 f. Hemodialysis chairs located on station #10, #15,#16 and #25 were observed with broken vinyl on chair arm rest and chair footrest.”

“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: 17959 Based on review of the treatment flowsheet on 03/12/2024 and 03/13/2024 at 1:00 PM till 4:00 PM it was identified that the facility failed to follow physicians’ orders in the BFR and 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 19 records reviewed (RR), (RR#10. #18 and #19) Findings include: 1. RR# 10 is a 59-year-old male patient admitted to the facility on 01/03/2023 with a diagnosis of End Stage Renal Disease. This patient’s hemodialysis treatment order dated 02/22/2024 establishes that this patient must receive treatment by CV Catheter Tunneled, a BFR 400 and DFR 800. Review of hemodialysis flowsheet dated from 02/22/2024 through 03/12/2024 with the agency Clinical Manager (employee #2) on 03/12/2024 at 3:10 PM evidenced that treatment was given on 03/09/2024 with a BFR of 400 and no evidence of BFR registered by the dialysis machine when the nurse initiated the hemodialysis treatment at 7:31 AM the BFR was maintain on 800. 2. RR#18 is a 44-year-old male patient admitted to the facility on 04/15/2022 with a diagnosis of End Stage Renal Disease. This patient’s hemodialysis treatment order dated 02/01/2024 establishes that this patient must receive treatment by CV Catheter, a BFR 400 and DFR 800. Review of hemodialysis flowsheet dated from 02/01/2024 through 03/11/2024 with the agency Clinical Manager (employee #2) on 03/13/2024 at 10:00 AM evidenced that treatment not given on 02/02/2024 because the patient refuses the treatment per the presence of the housekeeping employee (#2). The hemodialysis treatment was programed for the next date 02/03/2024. On 02/07/2024 and 02/16/2024 the patient was absent from the treatment. On 02/12/2024 at 6:00 PM and 6:30 PM during the patient received the hemodialysis treatment the BFR was maintained in 350 not according with the physician order. On 02/21/2024 the patient initiated the hemodialysis treatment at 17:02 (5:02 PM) and ended at 21:10 (9:10 PM) the treatment sheet was maintained in blank and no evidence of BFR, DFR and vital signs during old of the treatment included when the patient ended the hemodialysis treatment. No evidence of documentation related the reason per the machine did not provide this information. 3. RR#19 is an 82-year-old female patient admitted to the facility on 12/19/2017 with a diagnosis of End Stage Renal Disease. This patient’s hemodialysis treatment order dated 03/09/2024 establishes that this patient must receive treatment by AV Graft Synthetic, a BFR 400 and DFR 800. Review of hemodialysis flowsheet dated from 02/20/2024 through 03/09/2024 with the agency Clinical Manager (employee # 2) on 03/12/2024 at 1:30 PM evidenced that treatment was given on 02/22/2024 with a BFR of 400 and no evidence of BFR registered by the dialysis machine when the nurse ended the hemodialysis treatment at 2:57 PM the BFR was maintain on 0/300. On 03/09/2024 the BFR was maintained at 300 per four times not according with the physician order of 400. No evidence of documentation related the reason to maintain the BFR in 300. 4. The facility failed to maintain to ensure that the medical record includes accurate information related with the patient’s individual dialysis treatment prescription and parameters administered.”