Fmc Rio Piedras

“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: 51782 Based on observations made of the treatment area, during the first and second shift of 04/14/2025 from 8:00 AM through 2:00 PM, it was determined that the facility failed to monitor the environment to ensure that it is sanitary to reduce possible transmission of infectious agents within and between units related to the lack of adherence of “standard precautions”. Findings include: Clinical Manager (employee #8) provided facility’s policy Version 8 last update on 05/02/2024, Testing of Residual Bleach Using Water Check, RC Residual Chlorine Reagent Test Strips on 04/15/2025 at 9:00 AM. Policy states in page 3, in section 3 that the personal inspect the bottle of Water Check, RC Test Strips to ensure: the bottle is dated, initiated and not expired. 1. During observations conducted in the hemodialysis treatment area, on 04/14/2025 from 8:00 AM through 2:00 PM, and interview with facility nursing supervisor (employee #4) the following was observed: a) On 03/11/2025, at 9:24 A.M., one (1) container of Water Check Residual Chlorine, Lot number 2407321021, Expiration date 2027-01, it was observed open without opening date and the employee’s initials. Clinical Manager (employee #8) provided facility’s policy Version 9 last update on 02/06/2023, Medication Preparation Administration on 04/14/2025 at 3:00 PM. Policy states in page 2, in section of labeling vials that the personnel must place the date and time the vial was opened on the medication label along with their initials. 2. During observations conducted in the hemodialysis unit; medication area, on 04/14/2025 from 8:00 AM through 2:00 PM, and interview with facility nursing supervisor (employee #4) the following was observed: a) On 04/15/2025, at 11:35 A.M., Two (2) bottles of Promethazine Hydrochloride 25mg tablets, Lot number Z403590, Expiration date 2026-JUN-30, it was observed open without opening date and the employee’s initials. b) On 04/15/2025, at 11:42 A.M., One (1) bottle of extra strength Antiacid calcium carbonate 750mg tablets, Lot number 1273831, Expiration date 2027 JUL, it was observed open without opening date and the employee’s initials. c) On 04/15/2025, at 11:53 A.M., One (1) vial of Doxercalciferol injection 4mcg per 2mL, Lot number C5E1311A, Expiration date 2026-07, it was observed open without opening date and the employee’s initials. Clinical Manager (employee #8) provided facility’s policy Version 2 last update on 04/05/2021, Storage of Supplies on 04/14/2025 at 3:00 PM. Policy states in page 1, that supplies must be rotated First in First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date. 3. During observations conducted in the hemodialysis unit; medication area, on 04/14/2025 from 8:00 AM through 2:00 PM, and interview with facility nursing supervisor (employee #4) the following was observed: a) On 04/15/2025, at 10:22 A.M., Seven (7) syringes 1 ml expired on 04/08/2025 were observed. Clinical Manager (employee #8) provided facility’s policy Version 4 last update on 05/06/2024, Access Assessment and Cannulation on 04/15/2025 at 9:30 AM. Policy states in page 3, in section 9 that remove gloves and perform hand hygiene. Don new gloves. Note: To clarify gloves changes during the cannulation procedure: After assessing the access, staff must perform hand hygiene and Don new gloves. With the new gloves, staff must perform the full cannulation procedure including skin disinfection, lidocaine administration (if applicable) and cannulation. 4. During observations conducted in the hemodialysis treatment area on 04/14/2025 at 9:58 M, the following was observed: a) It was observed that during the arteriovenous fistula initiation procedure, (employee #3) after assessing vascular access and verifying the patency, she did not remove gloves and did not wash her hands; she used the same gloves to disinfect the vascular access and performed the cannulation. 47384 5. Paramedics were observed entering the Unit and attending patients without performing the proper handwash process. 6. Regular and biomedical trash containers were observed touching machines and water lines. 7. Maintenance personnel was observed transferring regular trash into 32-gallon trash containers and trash falling from bag. 47632 8. During the observations made in the treatment area on 04/14/2025, the following were found: a. On 04/14/2025 at 12:46 PM, the patient located on station #13 was eating in the station. b. On 04/14/2025 at 12:58 PM, the patient located on station #28 was eating in the station. The facility failed to ensure that patients did not ingest food during dialysis treatment according to “Standard Precautions”.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 47632 Based on an observation made on treatment area, during the first and second shift on 04/14/2025 from 8:30 AM through 2:00 PM, it was determined that the facility failed to ensure that patients follow instructions related to the hazards of eating while on dialysis for 4 out of 30 observations at patients’ stations (#12, #13, #28 and #32) and failed to ensure staff members wear gowns, face shields, eye wear, or masks to protect themselves. Findings include: Review of facility’s Policy &Procedures, # 45279 FMS Version:5 Eating and drinking hot liquids on dialysis policy last updated on 02/01/2023 established that the patient who need a snack and/or drink should consume any food or beveragein the waiting room before or after their treatment. During the observations made in the treatment area on 04/14/2025, the following was found: 1. On 04/14/2025 at 12:46 PM, the patient located on station # 13 was eating in the station.. 2. On 04/14/2025 at 12:58 PM, the patient located on station # 28 was eating in the station. The facility failed to ensure that patients did not ingest food during the entire dialysis treatment area according to facility policy. 51782 3.. On 04/14/2025 at 8:20 AM, the patient located on station #32 was eating donuts. 4. On 04/14/2025 at 12:58 PM, the patient located on station # 12 was eating onions chips. 47384 5. On 04/14/2025 at approximately 8:15 AM, one (1) nursing staff member (employee #9) was observed wearing the isolation gown backwards, leaving her uniform exposed to spurting or spattering of blood during treatment.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 47632 Based on an observation made in the treatment area on 04/14/2025, it is determined that the facility failed to maintain the dialysis station clean and disinfected of items placed on top or side of the treatment chair. Findings include: During observation of the treatment area, station #20, # 22, #23 and #24, patients were observed having personal belongings either hanging from or on top of the folding table of the treatment chairs.”

“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: 47632 Based on observations made in the treatment area on 04/14/2025, it was determined that the facility failed to ensure that patients receive treatment in a manner that allows staff to have full view of patients access site for the first and second shift at patients’ stations #1, #5, #7, #26, #33 and #34. This deficient effect 6 out of 34 stations patients observed receiving treatment. Findings include: During the observations made in the treatment area on 04/14/2025 at 8:00 AM through 2:00 PM, the following were found: 1. On 04/14/2025 at 12:25 PM, the patient was located on station # 5, it was observed that the vascular access was covered with sheets. 2. On 04/14/2025 at 12:28 PM, the patient was located on station # 7; it was observed that the vascular access was covered with sheets. 3. On 04/14/2025 at 12:33 PM, the patient was located on station # 34, it was observed that the vascular access was covered with sheets. The facility failed to ensure vascular access sites should be seen by staff members during all dialysis treatment. Allowing patients to cover access provides an opportunity for accidents of needle. 51782 4. On 04/14/2025 at 8:10 AM patient #20, located on station #26, was observed with her left arm fistula vascular access covered with a blanket while receiving treatment. 5. On 04/14/2025 at 8:15 AM patient #21, located on station #33, was observed with her right subclavian catheter vascular access covered with a shirt and blanket while receiving treatment. 6. On 04/14/2025 at 8:25 AM the patient was located on station #1, was observed with his left arm fistula catheter vascular access covered with a blanket while receiving treatment.”

“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 04/14/2025 and 04/15/2025 from 8:30 AM through 3:00 PM, it was determined that the facility failed to maintain Life Safety measures that comply 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. Unattended medical screens were observed throughout treatment unit obstructing means of egress. 2. At the time of the survey there was no written evidence that the two (2) fire doors in the facility had been inspected. After further observation, none of the fire doors or frames had the fire rating decal to validate fire rating. To ensure 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. 3. Unprotected penetration by air conditioning ducts was observed between units waiting area and treatment area.”

“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: 47632 Based on nineteen records reviewed (RR), review of policies and procedures and interview with Clinical Manager (employee #8), it was determined that the facility failed to follow established procedures after identifying patients’ high blood pressure (BP) or low blood pressure (BP) during dialysis treatment for 5 out of 19 records reviewed (RR #10, #12, #15, #5 and #11). Findings include: During the flowsheet review performed on 04/14/2025 and 04/15/2025 at 9:00 AM to 3:30 PM the following were found: 1. RR# 10 is a 79-year-old female admitted to the facility on 07/26/2023 with a diagnostic End Stage Renal Disease. During the record review performed on 04/14/2025 at 2:52 PM, the hemodialysis treatment three times a week for four hours, Dialyzer 160 NRE Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 500 and Patient Dry Weight (EDW) of 60.5 kilograms (kg). a. On 02/21/2025 at 7:05 AM, it was revealed that the Blood Pressure (BP) was 194/71mg/Hg, and at 8:59 AM it was revealed that the BP was 197/79 mg/Hg. No evidence was found of nursing interventions, documentation for hypertension or notification of the physician. 2. RR# 12 is a 62-year-old male admitted to the facility on 07/31/2018 with a diagnostic End Stage Renal Disease. During the record review performed on 04/14/2025 at 1:20 PM, the hemodialysis treatment three times a week for four hours, Dialyzer 180 NRE Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 72 kilograms (kg). a. On 04/01/2025 at 5:43 AM, it was revealed that the BP was 189/107mg/Hg, at 5:45 AM it was revealed that the BP was 178/118mg/Hg, and at 6:11 AM it was revealed that the BP was 156/101mg/Hg. b. On 04/03/2025 at 9:27 AM, post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing, evaluating the patient’s ambulatory status was unassisted. c. On 04/08/2025 at 9:26 AM, post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. d. On 04/10/2025 at 5:29 AM, pre dialysis treatment revealed that BP sitting was 1190/110mg/Hg and standing 196/104mg/Hg and post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. e. On 04/12/2025 at 9:23 AM, post dialysis revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. No evidence was found of nursing interventions, documentation for hypertension or notification of the physician. 3. RR# 15 is a 58-year-old male admitted to the facility on 02/05/2020 with a diagnostic End Stage Renal Disease. During the record review performed on 04/15/2025 at 10:41 AM, the hemodialysis treatment three times a week for four hours, Dialyzer 250 NRE Optiflux, Blood Flow Rate (BFR) of 450, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 154.5 kilograms (kg). a. On 03/31/2025 at 7:37 AM, pre and post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. b. On 04/02/2025 at 5:37 AM, pre and post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. c. On 04/07/2025 at 7:52 AM, pre and post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. At 8:40 AM, it was revealed that the BP was 167/110mg/Hg, at 9:02 AM it was revealed that the BP was 190/100mg/Hg, at 9:35 AM, it was revealed that the BP was 182/116mg/Hg, at 10:06 AM, it was revealed that the BP was 170/117mg/Hg, and at 11:08 AM, it was revealed that the BP was 129/106mg/Hg. d. On 04/09/2025 at 5:39 AM, pre and post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. e. On 04/11/2025 at 5:43 AM, pre and post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. No evidence was found of nursing interventions, documentation for hypertension or notification of the physician. The Clinical Manager (employee #8) provided facility’s policy Version 3 last update on 07/01/2024, Intradialytic Hypotension on 04/14/2025 at 3:00 PM. Policy states in page 1, that the staff will report intradialytic hypotensive episodes to the to the nurse in charge. States to the frequent intradialytic hypotensive episodes the nurse in charge will report to the physician. 4. RR# 5 is a 60-year-old female admitted to the facility on 01/31/2019 with a diagnostic End Stage Renal Disease. During the record review performed on 04/14/2025 at 1:20 PM, the hemodialysis treatment three times a week for three hours and fifteen minutes, Dialyzer 160 NRe Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 700 and Patient Dry Weight (EDW) of 45.5 kilograms (kg). a. On 04/03/2025 at 1:38 PM, it was revealed that the Blood Pressure (BP) was 77/48mg/Hg, at 2:01 PM it revealed that the BP was 89/54 mg/Hg and at 2:31 PM it revealed that the BP was 88/54 mg/Hg. No evidence was found of nursing interventions, documentation for hypotension or notification episodes to the nurse in charge. 5. RR# 11 is a 88-year-old male admitted to the facility on 06/27/2022 with a diagnostic End Stage Renal Disease. During the record review performed on 04/15/2025 at 9:58 AM, the hemodialysis treatment three times a week for four hours, Dialyzer 180 NRe Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 76.5 kilograms (kg). a. On 04/07/2025 at 6:35 AM, it was revealed that the Blood Pressure (BP) was 195/75mg/Hg, at 7:05 AM it revealed that the BP was 195/98 mg/Hg, at 7:34 AM it revealed that the BP was 190/102 mg/Hg, at 8:39 AM it revealed that the BP was 196/99 mg/Hg and at 9:04 AM it revealed that the BP was 189/105 mg/Hg. b. On 04/09/2025 at 7:03 AM, it was revealed that the Blood Pressure (BP) was 177/107mg/Hg and at 10:40 AM it was revealed that the BP was 182/96 mg/Hg. c. On 04/11/2025 at 6:24 AM, it was revealed that the Blood Pressure (BP) was 190/106mg/Hg, at 6:25 AM it revealed that the BP was 194/104 mg/Hg, at 6:34 AM it revealed that the BP was 190/89 mg/Hg, at 7:07 AM it revealed that the BP was 193/107 mg/Hg, at 8:05 AM it revealed that the BP was 192/112 mg/Hg, at 8:32 AM it revealed that the BP was 184/102 mg/Hg and at 9:02 AM it revealed that the BP was 175/104 mg/Hg. 6. No evidence was found of nursing interventions, documentation for hypertension or notification of the physician.”

“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: 47632 Based on a nineteen-record reviewed (RR) on 04/14/2025 through 04/15/2025, it was determined that the facility failed to follow physician’s orders in the Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR) during dialysis treatment and documentation in the management of the patients BFR and DFR 4 out of 11 records reviewed (R.R #10, #12, and #19). Findings include: 1. RR# 10 is a 79-year-old female admitted to the facility on 07/26/2023 with a diagnostic End Stage Renal Disease. During the record review performed on 04/14/2025 at 2:52 PM, the hemodialysis treatment three times a week for four hours, Dialyzer 160 NRE Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 500 and Patient Dry Weight (EDW) of 60.5 kilograms (kg). a. On 02/21/2025 at 6:02 AM, 6:34 AM, 7:05 AM, 7:32 AM, 8:05 AM, 8:33 AM, and 8:59 AM the DFR was increased to 800. No evidence was found of the justification on the nurse note or authorized increase from the physicians. 2. RR# 12 is a 62-year-old male admitted to the facility on 07/31/2018 with a diagnostic End Stage Renal Disease. During the record review performed on 04/14/2025 at 1:20 PM, the hemodialysis treatment three times a week for four hours, Dialyzer 180 NRE Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 72 kilograms (kg). a. On 04/08/2025 at 5:38 AM, 5:39 AM, 6:24 AM, 6:43 AM, 7:03 AM, 7:31 AM, 7:57 AM, 8:46 AM, 9:05 AM and 9:26 AM the DFR was decreased to 500. b. On 04/12/2025 at 5:44 AM, 5:48 AM, 6:15 AM, 6:47 AM, 6:57 AM. 7:32 AM, 7:57 AM, 8:29 AM, and 9:23AM the DFR was decreased to 500. No evidence was found of the justification on the nurse note or authorized decrease from the physicians. 3. RR #19 is a 62-year-old female admitted to the facility on 02/01/2025 with a diagnostic End Stage Renal Disease. During the record review performed on 04/15/2025 at 8:13 AM, the hemodialysis treatment three times a week for four hours, Dialyzer 180 NRE Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 80.50 kilograms (kg). a. On 04/02/2025 at 10:35 AM, 10:36 AM, 10:54 AM, 11:31 AM, 12:03 PM, 12:30 PM, 1:02 PM, 1:33 PM, and 2:03 PM the DFR was decrease to 500. 4. No evidence was found of the justification on the nurse note or authorized decrease from the physicians.”

“MR-COMPLETE RECORDS PROMPTLY CFR(s): 494.170(b)(1) (1) Current medical records and those of discharged patients must be completed promptly. This Standard is not met as evidenced by: 47632 Based on observation of nineteen record reviews (RR), and interview with facility Clinical Manager (employee #8), it was determined that the facility failed to ensure that the discharge summary must be completed promptly. This deficiency was identified in 1 out of 19 records reviewed, (RR#10). Findings include: 1. RR# 10 is a 79-year-old female admitted to the facility on 07/26/2023 with a diagnostic End Stage Renal Disease. During the records review conducted on 04/14/2025 at 2:52 PM, the discharge summary sheet was observed without date or signature of the physician. The patient was discharged from the facility and transferred to the Biomedical Application of San Juan because it was closer to her home. The Clinical Manager (employee #8) was interviewed on 04/14/2025 at 3:42 PM, who stated that the patient was discharged from the facility on 03/05/2025 and that the discharge summary was completed on 03/07/2025, but the date and physician’s signature were missing.”

“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 with Clinical Manager (employee # 1), it was determined that the facility failed to monitor the environment and infection control standard of practice during dialysis treatment to ensure that it is sanitary to reduce possible transmission of infectious agents within and between the unit related to the lack of adherence of standard precautions. Findings include: A. During the Infection Control Survey, physical environment and connection and disconnection process on 05/06/2024 and 05/07/2024 from 8:00 AM through 4:00 PM at the hemodialysis unit and other areas of the hemodialysis unit: a. On 05/06/2024 at 8:00 AM housekeeping employee (#8) left the administrative area unit with the cleaning cart without gloves, without mask he left the cart in front of the main door and when he saw the surveyors he when inside again and left with gloves and mask and then began to clean the patient bathroom in the waiting room area. b. On 05/06/202 at 8:10 AM housekeeping employee (#8) was observed to enter the Janitor area with the cleaning cart, hand washing dispenser was observed at the far left of the door, he left the cleaning cart in front of the door, he did not wash hands with soap and water, he went out with a pot and a roll of paper napkins and entered the treatment unit, he did not wash his hands, he did not put a protective gown and continued inside the unit until he reached the supply warehouse. c. On 05/06/2024 at 9:10 AM a small room was observed between the weight and the main entrance and exit door of patients receiving hemodialysis. The door was closed but without lock and inside there were three large metal shelves with patient records, dust was detected on the files. Room of files being open and is in the area where the main entrance to receive dialysis patients, family members and ambulance personnel which contributes to risks. Dark ceiling with evidence of fungus due to moisture is observed. d. On 05/06/024 at 9:15 AM wall in front of stations one to seven with paint peeling is observed. e. During observation of the disconnection process of the first shift on 05/06/2024 at 9:20 AM performed at station #2 patient with amputation of both lower extremities the Registered Nurse (RN) #3 initiated the disconnection and at the same time management the computer, then with the same gloves, administer the saline solution and complete the disconnection process with the same gloves all the time. Then RN3 discard the lines and the syringes in station number three, did not removed the gloves, went to the patient station took the blood pressure (B/P) but did not disinfect the stethoscope before and after used and did not perform the auscultation with the stethoscope. When the nurse ended the disconnection process, she took the patient to weigh and accompanied to the exit, then she went to the station removed her gloves applied hand sanitizer, then she took the screen to place it in the area. The nurse went to the medical supplies area, she took a pair of gloves and gloved her hands, however the nurse did not wash her hands or used hand sanitizer. The nurse went to station number two and continued writing on the computer. Then she began to clean and disinfect the treatment chair, she removed gloves but did not wash her hands or used hand sanitizer went to the supplies area took two gloves she put them on, and the next patient was entered. f. On 05/06/024 at 9:10 AM during the disconnection process at station #2 a patient was observed wearing a mask, but it was not covering nose or mouth. The nurse (RN #6) put her hands in the glove box, placed gloves without hand washing, removed a line and discarded, then removed gloves, dry clean and placed gloves and removed second line, placed gauze and while the patient pressed on the left forearm, RN #6 removed gloves, introduced hands into the glove box, gloved hands but did not dry wash hands. She then went to station #12 and placed adhesive tape on the patient’s left arm. Removed gloves and washed hands with soap and water. g. On 05/06/2024 at 9:30 AM ambulance personnel were observed entering the unit with masks and plastic gowns which they brought from the street, they washed their hands, put on gloves, weighed the patient, and took them to their treatment chair, then they left the unit with the same gowns and masks, they only removed gloves but did not wash their hands. h. On 05/06/2024 at 9:30 AM and during the hemodialysis treatments, it is observed that the nursing staff uses the protective screens during, but they are not cleaned after each use and are placed in front of the area where patients place their belongings. i. On 05/06/2024 at 9:35 AM the RN #7 went to the supply area, put her hands in the glove box and removed two gloves, then took two gauzes, put on the gloves, handled the patient machine in station #3, provided the two gauzes to the RN of station #2 who was disconnecting the patient and then went to station #3, took the patient’s blood pressure, removed gloves and washed hands ann dry. At 10:05 AM it was observed that a patient from station #3 got out of his treatment chair alone and sat in his wheelchair while RN #7 was assisting patient from station #4. RN #9, who was performing the process of disconnecting the patient at station #2, removed his gloves, went to the supply area, introduced his hands inside the box, removed two gloves and then took out two gauzes, went to station #2, patient with bleeding, put on gloves but did not dry wash his hands before putting on the gloves. j. On 05/06/2024 at 9:45 AM RN #11 had his/her mask but kept it below his/her nose during the process of disconnecting station #1 patient with catheter at right side of her neck. After disconnecting, he/she removed gloves and washed hands with soap and water. Then returned the protective screen and placed it in front of the designated area for patients’ belongings, but no disinfection of the screen was performed after use. When leaving the patient, did not wash hands. k. On 05/06/2024 at 10:00 AM second shift patient station connection #12 do not wash hands. RN#11 always keeps his/her mask below the nose. Performed dry hand washing and then took patient walker to the designated area, then went to station #14, removed the patient’s belongings, and took his bundle to the designated area. Then washed hands with soap and water, put on gloves and began the connection process. l. On 05/06/2024 at 10:05 AM RN #12 took undisinfected protective screen to station #28 to begin the connection process. m. On 05/06/2024 at 10:13 AM patient sheet is observed touching the floor during and after the connection process performed by RN #9. n. On 05/06/2024 at 10:20 AM at station #14 papers were seen on the floor. In station #18 you can see scissors and paper. Patient placed his briefcase directly on the floor. Protective screen was placed in front of station #19 and was not disinfected by RN #11. At 10:25 AM water is seen directly on the floor in front of treatment chair and dialysis machine. At 10:30 AM between station #20 and #21, white spots were observed on the floor and on the base of the dialysis machine. All edges of the walls and floor are opaque, dusty, and dirty edges on the edge of the Emergency Exit Door from down to stations #8 to #14 and from stations #15 to #21. o. On 05/06/2024 at 10:35 AM on the right side of station #34 and in the sink of the clean area, RN #13 is observed performing a disconnection process. During the infection control inspection process, an unidentified four-drawer brown cart with no safety lock was observed in the company of ATOM 35 (Employee #10). 1. In drawer #1 the following was found: gauze, alcohol pads, needles, adhesive tape, tweezers, Chloraprep and other materials. 2. In drawer #2 you will find fistulas needle sets, blue pads, and masks. 3. Drawers #3 and #4 were found empty. 4. From the items found inside the drawers, the following expired materials were identified: - Two Hemodialysis Blood Tubing Sets, two bags of Sodium Bicarbonate and two bags of 0.9% Sodium Chloride Injection USP of 1000 ml. with an expiration date of July 2023. - Ten Disposable AV Fistula Needle Sets with Expiration Date April 13/2024 Lot 2102010926 - Two Disposable AV Fistula Needle Sets with expiration date December/8/2023 Lot 2002012755. p. On 05/06/2024 at 10:10 AM in the company of ATOM 34 (employee #4) you can see a plastic cart with two slats to place the gallons of acid to be used during hemodialysis treatments. On the top tablet, 14 gallons of acid placed on the blue pad were identified. On the second shelf a deteriorated cardboard box was observed and inside the box were found 24 lines of ‘Hemodialysis Blood Tubbing Set and a Safety Fistula Needle 2.0 x 300 mm Lot. 19c13D. ’’ This tablet had no blue pad and the entire base of the tablet had dry acid content. q. The RN’s failed to maintain hand hygiene procedures accordingly with hand hygiene standards of practice and accepted guidelines for infection control. The RN’s failed to follow infection control prevention measures. This practice is a vehicle of transmission and risk of cross contamination.. 47384 A. During observation of the treatment unit on 05/06/2024 through 05/07/2024 the following was noticed: 1. Employees were observed entering the Unit and hanging gowns to be used when reentering. It was observed that the string to adjust the gown had long size and part of the bottom of the gowns stayed touching the floor. 2. Employees were observed entering the Unit and attending patients without performing the proper handwash process 3. Sensipar pill was found on the floor in front of station #2. 4. Cardboard particles and dust was found on drawers of equipment Pods. 5. Insects found on floor in front of emergency exit door and on plastic cover of light fixtures. 6. Trash was observed on the surroundings of building and parking area.6. Trash was observed on the surroundings of building and parking area.”

“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, interview with the ATOM 34 (employee #4), and review of policies/procedures, 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. During evaluation of Preventive Maintainance (PM) documentation it was observed that some errors were committed on the entry of operating hours on maintainace logs. 2. During observational tour of the treatment area, chairs were observed with broken vinyl on seat, backrest and footrest. ( #9, #11, #19, #26, #29, #33) 3. During observational tour of the treatment area it was observed that stations ( #2, #7, #25, #26, #31) were missing emergency desconection kits on one of their sides.”

“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: 15884 Based on twenty-two records reviewed (RR), review of policies and procedures interview with patients and with Facility Manager (employee #1), it was determinate that the facility failed to act upon patients’ needs, and sensitivity to his or her psychological needs and ability to cope with ESRD. This deficient practice had the potential to affect ----------of cases Findings include: During review of complaint log of year 2023 and the months of January, February, March, and April 2024 on 05/07/2024 at 11:00 AM to 1:00 PM the following was identified: Two complaints were filed by patients and relatives, one on 09/27/2023 and one on 02/23/2024. Both complaint concerns include the report of disagreement by patients with the disrepair and status of the hemodialysis treatment chairs. During interview on 05/07/2024 at 12:55 PM with the Facility Manager (employee #1) stated that facility is working with the requisition of new hemodialysis treatment chairs to repair, those chairs that are disrepair since the month of November 2023. Facility Manager stated during interview on 05/07/2024 at 1:15 PM that facility had been confronting situations with the hemodialysis treatment chairs vendor at the Unites States and that there is a delay in the provision of the requested hemodialysis treatment chairs and that this situation and delay were reported to all patients and relatives. The Facility Manager was asked on 05/07/2024 at 1:25 PM if something additional to the plan to wait for the new chairs to deal with the situation referred by those two patients were performed. The Facility Manager stated in an interview on 05/07/2024 at 1:30 PM that she had knowledge that technical personnel consider fixing those chairs that can be repaired, but also confront situations with the person who used to do upholstery work for the company. 47384 During random patient #1 interview input was recieved on the treatment chair conditions. The patient states that the condition of the chairs is unacceptable. He says that on repeated occasions he has requested that the chairs be changed. He stated that he complained to the network on september due to the conditions of the chairs. Patient #1 stated that the facility has some x-large chairs that accomodate his needs but are not always available for when he is in treatment. During random patient #2 interview input was recieved on the treatment chair conditions. The patient states that she requested a meting with facility’s manager regarding chair conditions, this meeting was granted but stated that no results after meeting have been observed. Patient #2 states that she feel ther is no empathy towards the patients.The patient reports that sitting in chairs for four hours feeling the rush is unacceptable.”

“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: 15884 Based on, twenty two records reviewed (RR), review of policies and procedures and interview with Facility Manager (employee #1), it was determinate that the facility failed to follow established procedures after identify patients’ high blood pressure (BP) or low blood pressure (BP) during dialysis treatment for 7 out of 22 records reviewed (RR #2, #5, #6, #7, 8, #10 and #15). Findings include: During flowsheet review performed on 05/06/2024 at 1:00 PM to 5:00 PM the following was found: Upon review of the facility’s policy Title: Guidelines for prevention, recognition and treatment of hypervolemia and hypertension last update on 09/07/2021, on 05/06/2024 at 4:30 PM. Policy clearly stated on the procedures that during hemodialysis treatment personnel will recognized, report and immediately address diastolic blood pressures greater than 100 millimeter mercury (mm/Hg). The policy stated that if diastolic blood pressure is greater than 100 mm/hg; personnel must assess patient’s condition and determine if further nursing interventions are needed including notifying the physician for additional orders/interventions. 1. RR #8 is a 57-year-old female patient admitted to the facility on 02/24/2024 with diagnosis of End Stage Renal Disease (ESRD). During the record review performed on 05/06/2024 at 2:25 PM, it was found that patient has hemodialysis treatment three a week for four hours, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 800, Dialyzer with 180 NRe Optiflux and patient Dry Weight (EDW) 118.5 kilogram (kg). a. On 04/30/2024 at 11:08 AM it was revealed that the BP was 124/107 mm/Hg. No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify high blood pressure. b. On 04/25/2024 record review revealed that patient present high blood pressure at 8:24 AM, BP was 169/108 mm/Hg, at 10:00 AM BP was 165/104 mm/Hg, and at 10:22 AM BP was 155/102 mm/Hg. No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify high blood pressure. c. On 05/06/2024 at 3:55 PM during interview Facility Manager (employee #1) stated that after reviewing the medical record she did not find evidence related with nursing personnel interventions followed after the patient presented high blood pressure on 04/30/2024 and on 04/25/2024. She stated that if during treatment personnel identify high blood pressure, personnel must recheck blood pressure, reposition the electronic cuff or use manual cuff for high blood pressure readings to recheck blood pressure. She also stated that if blood pressure is more or equal to 100 mm/hg systolic; personnel must assess patient’s condition and notify the patient’s physician. The facility Manager (employee #1) was asked by the surveyor on 05/06/2024 at 4:50 PM if she had knowledge that last year during recertification survey 08/11/2023 the same deficient practice in relation with the management of patients who present high blood pressure (BP) or low blood pressure (BP) during dialysis treatment was cited. The facility Manager (employee #1) stated on interview on 05/06/2024 at 4:55 PM that she is aware of this, and that facility had in place a monitoring and quality assessment plan to address those deficiencies, but they did not been able to correct this aspect on the 100 percent of cases 20423 Upon review of the facility’s policy Title: Guidelines for prevention, recognition and treatment of hypervolemia and hypertension last update on 09/07/2021, on 05/06/2024 at 4:30 PM. Policy clearly stated on the procedures that during hemodialysis treatment personnel will be recognized, report and immediately address systolic blood pressures less than 20 mm/Hg. The policy stated that if systolic blood pressure is less than 20 mm/hg; personnel must assess patient’s condition and determine if further nursing interventions are needed including notify the physician for additional orders/interventions. 2. RR #2 is a 72-year-old female patient admitted to the facility on 03/19/2015 with diagnosis of ESRD. During the record review performed on 05/06/2024 at 10:30 AM, it was found that patient has hemodialysis treatment three a week for four hours, BFR of 350, DFR of 500, Dialyzer with 160 NRe Optiflux and patient EDW 73.50 kg. a. On 05/02/2024, the nurse failed to document the B/P in stand position pre and post treatment, the nurse documented that patient ambulated without assistance. b. On 05/02/2024 according to the physician order 11/08/2023 the B/P was taken every 30 minutes; however, B/P was taken every 71 minutes during the period of 7:58 AM until 9:09 AM. 3. RR #5 is a 72-year-old male patient admitted to the facility on 02/07/2024 with diagnosis of ESRD. During the record review performed on 05/06/2024 at 03:39 PM, it was found that patient has hemodialysis treatment three a week for four hours, BFR of 350, DFR of 500, Dialyzer with 160 NRe Optiflux and patient EDW 61.50 kg. a. On 04/22/2024, on 04/24/2024, on 04/29/2024 the nurse failed to document the B/P in stand position pre and post treatment, the nurse document that patient ambulated without assistance. b. On 04/29/2024 at 17:25 PM revealed that the BP was 166/101 mm/Hg, at 19:23 PM revealed that the BP was 176/106 mm/Hg, at 19:51 PM revealed that the BP was 178/100 mm/Hg and at 20:14 PM revealed that the BP was 168/105 mm/Hg. No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify high blood pressure. c. On 05/01/2024 according to the physician order 02/07/2024 the B/P was taken every 30 minutes; however, B/P was taken every 68 and 77 minutes during the period of 18:12 PM until 19:18 PM and 19:18 PM until 2025. 4. RR #6 is a 45-year-old male patient admitted to the facility on 01/20/2020 with diagnosis of ESRD. During the record review performed on 05/06/2024 at 01:20 PM, it was found that patient has hemodialysis treatment three a week for four hours, BFR of 400, DFR of 500, Dialyzer with 180 NRe Optiflux and patient EDW 96.50 kg. a. On 04/23/2024, on 04/27/2024, the nurse failed to document the B/P in stand position pre and post treatment, the nurse documented that patient ambulated without assistance. 5. RR #7 is a 58-year-old female patient admitted to the facility on 02/20/2024 with diagnosis of ESRD. During the record review performed on 05/06/2024 at 02:57 PM, it was found that patient has hemodialysis treatment three a week for four hours, BFR of 400, DFR of 500, Dialyzer with 160 NRe Optiflux and patient EDW 60 kg. a. On 04/23/2024, on 04/26/2024, on 05/02/2024, the nurse failed to document the B/P in stand position pre and post treatment, the nurse documented that patient ambulated without assistance. At 13:25 PM it was revealed that the BP was 96/50 mm/Hg, no evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify low blood pressure. b. On 04/23/2024, at 13:25 PM it was revealed that the BP was 96/50 mm/Hg, no evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify low blood pressure. c. On 05/01/2024 according to the physician order 02/07/2024 the B/P was taken every 30 minutes; however, B/P was taken every 68 and 77 minutes during the period of 18:12 PM until 19:18 PM and 19:18 PM until 2025. d. On 05/02/2024 according to the physician order 02/07/2024 the B/P was taken every 30 minutes; however, B/P was taken every 57 minutes during the period of 13:38 PM until 14:31 PM. 6. RR #10 is a 56-year-old male patient admitted to the facility on 04/11/2024 with diagnosis of ESRD. During the record review performed on 05/07/2024 at 8:17 AM, it was found that patient has hemodialysis treatment three a week for four hours 15 minutes, BFR of 400, DFR of 800, Dialyzer with 180 NRe Optiflux and patient EDW 138 kg. a. On 04/27/2024 at 13:02 PM it was revealed that the BP was 99/66 mm/Hg. No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify low blood pressure. b. On 04/30/2024 at 13:05 PM revealed that the BP was 80/48 mm/Hg, at 14:02 PM revealed that the BP was 91/52 mm/Hg, at 14:25 PM revealed that the BP was 93/62 mm/Hg. No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify low blood pressure. According to the physician order 04/11/2024 the B/P was taken every 30 minutes, however B/P was taken every 68 minutes during the period of 13:05 PM and 14:02 PM. c. On 05/04/2024 at 16:03 PM it was revealed that the BP was 95/54 mm/Hg. No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify low blood pressure. 7. RR #15 is a 62-year-old male patient admitted to the facility on 04/27/2018 with diagnosis of ESRD. During the record review performed on 05/07/2024 at 10:00 AM, it was found that patient has hemodialysis treatment three a week for four hours, BFR of 400, DFR of 800, Dialyzer with 180 NRe Optiflux and patient EDW 82.5 kg. a. On 04/23/2024 at 09:06 AM it was revealed that the BP was 156/102 mm/Hg. No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify high blood pressure.”

“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 twenty two records reviewed (RR) and interview with the Assistant Manager (employee #4), it was determinate that the facility failed to ensure that changes in the Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR) are according with the physician orders, documented as part of hemodialysis treatment and are follow during the dialysis treatment for 4 out of 22 records reviewed (RR #6, #7, #10 and #20). Findings include: During flowsheet review performed on 05/06/2024 at 10:30 PM to 5:00 PM the following was found: Upon review of the facility’s policy Title: Guidelines for prevention, recognition and treatment of hypervolemia and hypertension last update on 09/07/2021, on 05/06/2024 at 4:30 PM. Policy clearly stated on the procedures that during hemodialysis treatment personnel will be recognized, report and immediately address diastolic blood pressures greater than 100 mm/Hg. The policy stated that if diastolic blood pressure is greater than 100 mm/hg; personnel must assess patient’s condition, and determine if further nursing interventions are needed including notify the physician for additional orders/interventions. 1. RR #6 is a 62-year-old female patient admitted to the facility on 02/27/2024 with diagnosis of End Stage Renal Disease (ESRD). During the record review performed on 05/06/2024 at 1:45 PM, it was found that patient has hemodialysis treatment three a week for four hours Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 500, Dialyzer with 180 NRe Optiflux and patient Dry Weight (EDW) 72 kilogram (kg). a.On 05/04/2024 at 2:03 PM patient receive hemodialysis treatment with BFR on 300. No evidence was found of the justification from the nurse documented or authorized decrease the BFR from the physician. b. On 04/30/2024 at 1:01 PM and 9:08 AM patient DFR was increased to 800. No evidence was found of the justification from the nurse documented or authorized to increase the DFR from the physician. c. On 04/23/2024 at 12:23 PM patient DFR was increased to 800. No evidence was found of the justification from the nurse documented or authorized to increase the DFR from the physician. 2. RR #20 is a 49-year-old female patient admitted to the facility on 10/09/2023 with diagnosis of End Stage Renal Disease (ESRD) and Diabetes Mellitus. During the record review performed on 05/06/2024 at 2:55 PM, it was found that patient has hemodialysis treatment three a week for three hours and thirty minutes, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of 800, Dialyzer with 180 NRe Optiflux and patient Dry Weight (EDW) 67 kilogram (kg). a.On 04/26/2024 at 8:21 AM patient receive hemodialysis treatment with a DFR on 500. The patient receives hemodialysis treatment from 8:21 AM until finish at 9:39 AM with a DFR on 500. No evidence was found of the justification from the nurse documented or authorized increase the DFR during hemodialysis treatment of patient RR #20 from the physician. b. On 04/24/2024 it was identified that the patient receive hemodialysis treatment from 6:25 AM through 9:51 AM with a DFR of 500. No evidence was found of the justification from the nurse documented or authorized decrease the DFR from the physician. c. On 05/06/2024 at 3:55 PM during interview Facility Manager (employee #1) stated that after reviewing the medical record she did not find evidence related with rationale for nursing personnel interventions when decrease the BFR to 300 of patient RR # 6 and increase the DFR to 800. Facility Manager (employee #1) did not find evidence on 05/06/2024 at 4:05 PM related with rationale for nursing personnel interventions when decrease de DFR of patient RR #20 to 500. Facility manager (employee #1) explain during interview 05/06/2024 at 4:20 PM that facility had policies and procedures who clearly establish that in cases were the patient is unable to achieve the prescribed BFR or DFR nursing personnel must notify the physician about. The facility Manager (employee #1) was asked on 05/06/2024 at 4:20 PM if she had knowledge that last year during recertification survey 08/11/2023 the same deficient practice in relation with the provision of hemodialysis treatment to patients with DFR and BFR different form physicians order was cited. Facility Manager (employee #1) stated on interview on 05/06/2024 at 4:25 PM that she is aware of this and that facility had in place a monitoring and quality assessment plan to address those deficiencies, but they did not been able to correct this aspect on the 100 percent of cases. 20423 3. RR #7 is a 58-year-old female patient admitted to the facility on 02/20/2024 with diagnosis of End Stage Renal Disease (ESRD). During the record review performed on 05/06/2024 at 2:57 PM, it was found that patient has hemodialysis treatment three a week for four hours BFR of 400, DFR of 500, Dialyzer with 160 NRe Optiflux and patient Dry Weight (EDW) 60 kilogram (kg). a.On 04/23/2024 at 11:38 AM patient receive hemodialysis treatment with DFR on 800 and at 12:55 PM patient receive hemodialysis treatment with BFR on 350. No evidence was found of the justification from the nurse documented or authorized increase the DFR from the physician. b. On 04/30/2024 at 1:01 PM and 9:08 AM patient DFR was increased to 800. No evidence was found of the justification from the nurse documented or authorized to increase the DFR from the physician. 4. RR #10 is a 56-year-old male patient admitted to the facility on 04/11/2024 with diagnosis of End Stage Renal Disease (ESRD). During the record review performed on 05/07/2024 at 8:17 AM, it was found that patient has hemodialysis treatment three a week for four hours 15 minutes, BFR of 400, DFR of 800, Dialyzer with 180 NRe Optiflux and patient Dry Weight (EDW) 148 kg. a.On 04/27/2024 at 12:43 PM and 13:26 PM patient receive hemodialysis treatment with BFR on 350. No evidence was found of the justification from the nurse documented or authorized increase the DFR from the physician. b. On 05/02/2024 at 13:03 PM and 14:30 PM patient DFR was decreased to 500. No evidence was found of the justification from the nurse documented or authorized to decrease the DFR from the physician. c. On 05/04/2024 at 14:10 PM patient DFR was decrease to 500. No evidence was found of the justification from the nurse documented or authorized to decrease the DFR from the physician.”