Fmc Vega Alta

“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 04/23/2025, it was determined that the facility failed to monitor the environment to ensure its sanitized and reduce the potential transmission of infectious agents within and between units, due to the lack of adherence to “standard precautions”. Findings include: Clinical Manager (employee #8) provided the facility policy Version :6 last update on 11/06/2023, Personal Protective Equipment on 04/24/2025 at 2:20 PM. The policy states on page 2 that all personal protective equipment must be removed before leaving the treatment area. 1. During the observations made at the unit with Charge Nurse (employee #4) from 04/23/2025 to 04/24/2025 from 8:00 AM to 3:00 PM, the following was observed: a. On 04/23/2025 at 8:03 AM, the patient at station #18 was observed to have the sheet touching the floor. b. On 04/23/2025 at 8:57 AM, the trash cans were observed touching parts of the dialysis machine at stations #12, #13, #14, #15, #16, #19, #17, #18, and #19 during dialysis treatment. c. On 04/23/2025 at 9:24 AM, a vial of Heparin 30,000 units in 30 (ml) milliliters was observed with no date or signature of when it was opened. d. On 04/23/2025 at 9:29 AM, a PRO SOURCE 15 (gm) gram pot of 887 ml was observed with no date or signature of when it was opened. e. On 04/23/2025 at 10:18 AM, nurses (employees #5, #6 and #7) were observed taking patients to the waiting room wearing personal protective equipment (PPE). f. On 04/23/2025 at 11:00 AM, Chlorox 1 of 100 wipes placed in the sink of nurses’ station #3 was observed. 51637 On April 24, 2025, at 12:00 PM with the clinical manager (employee #8) the policy “Hand Hygiene” was evaluated which was published on 11/06/2023 with reference number 47664 and states in page 3: “Patients should perform hand hygiene if able, prior to and after each dialysis treatment.” During the observations made in the treatment area on April 23, 2025, from 8:00 AM through 12:30 PM the following was observed: 2. Patient #22 was observed at station 26 during the disconnection process by fistula in the left arm which was being carried out by the nurse (employee #10). During the sealing process, it was observed that the patient broke the seal on three occasions and had contact with blood. At the culmination of the process once the sealing was completed, employee #10 was observed assisting patient #22 to walk to the scale area and then to the waiting room. No orientation or hand washing was observed being provided to the patient prior to leaving the treatment area. 3.One biohazard trash can was observed opened after used with blood lines expose.”

“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 04/23/2025, 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 #8, #9 and #12, patients were observed having personal belongings either hanging from or on top of the folding table of the treatment chairs.”

“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: 47632 Based on observation in the patient treatment area during the first and second shift on 04/23/2025 from 8:00 AM to 1:00 PM, it was determined that the facility failed to ensure a comfortable and functional environment for the patient and staff while patients are receiving treatments. Findings include: During interviews conducted at the unit on 04/23/2025 at 9:00 AM, the following was found: 1. During the interview on 04/23/2025 at 9:00 AM with the patient located at station #16, stated that he had no headphones and no control to listen to and change the television. He could not concentrate on the television because the noise from the other televisions did not allow him to hear his own. The interview conducted with Atom #34 (employee #9) on 04/23/2025 at 9:05 AM stated that she had the headset available, which was given to the patient at station #16 and the headset was also given to the patients on the unit. The audio wall and televisions were checked on 04/23/2025 and 04/24/2025 from 8:00 AM to 2:30 PM, and the following was found: a. station #9, the audio was not working. b. station #10, the audio was not working. c. station # 17, the audio did not work. d. station #21, the television did not work. e. station #22, the audio did not work. f. station # 25, the audio did not work. Atom #34 was interviewed again on 04/24/2025 at 2:20 PM, he stated that the controls were in place and that the TV had been ordered to replace the one that was not working. 51637 During the observations made in the treatment area on April 23, 2025, from 8:00 AM through 12:30 PM the following was observed: 2.The patient restroom labeled with a number 2 when opened there was a strong odor from the disinfectant (chlorine) used to clean it although the extractor fan was on. 3.In interview at 9:30 AM with ATOM #34 (employee #9) it was determined that the dilution of chlorine for cleaning should be 1:100.”

“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 observations made in the medication room on 04/23/2025, 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 observations made at the unit on 04/23/2025 from 8:00 AM to 10:00 AM, the following was observed: a. It was observed that the television in station #21 was not working. b. On the audio panel, the following stations were observed not working: #9, #10, #17, #22 and #25. c. A dark spot was observed in the drain at nurse station #3. d. Paper and plastic in the sink. 51637 During the observations made in the treatment area on April 23, 2025, from 8:00 AM through 12:30 PM the following was observed: 2. At 8:05 AM the door to the storage room located in the treatment area was unlocked. Upon entering the storage area there was no staff watching for unauthorized entry.”

“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 #13 and #18. This deficient effect 2 out of 27 stations patients observed receiving treatment. Findings include: During the observations made in the treatment area on 04/23/2025 at 8:00 AM through1 2:00 PM, the following were found: 1. On 04/14/2025 at 12:25 PM, the patient was located on station # 13, 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 # 18, it was observed that the vascular access was covered with sheets.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 17959 Based on records reviewed (RR), it was determined that the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the physician for 3 out of 22 sampled patients (Records Reviewed (RR) RR#6, RR#11and RR#18). Failure to follow the medical dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the patients receiving dialysis treatments. Findings include: 1. On 04/23/2025 at 10:38 AM the RR#6 revealed a 3 hours and 30 minutes dialysis treatment prescription, BFR 400 and DFR 800. Review of six “Treatment Sheet(s)” from 04/10/2025 through 04/22/2025, in the EMR, indicated the following: a. On 04/10/2025 - the BFR was documented 300 mL/min per 2 times, 400 mL/min per 6 times during the entire treatment and ended on 200. The DFR was documented in the treatment sheet at 600 per two times and 800 per seven times. According to the treatment sheet the patient starting the hemodialysis treatment at 7:01 AM however no evidence of the initial BP. 2. On 04/23/2025 at 2:10 PM the RR#11 revealed a 3 hours and 40 minutes dialysis treatment prescription, BFR 380 and DFR Autoflow 2.0. Review of six “Treatment Sheet(s)” from 04/10/2025 through 04/22/2025, in the EMR, indicated the following: a. On 04/10/2025 - the BFR initiated 385 mL/min per 2 times and was maintained 385 per 7 times during the entire treatment and ended on 200. According to the physician order the BFR was 380. b. On 04/12/2025 - the BFR was documented 300 mL/min per 3 times, them 385 mL/min per 2 times and them 400 per 1 time. The DFR was maintained at 600 per two times, then on 300 per one time. Ended the treatment with BFR on 385 and DFR on 800. c. On 04/15/2025 the patient iniciated the treatment at 6:22 AM and the BFR was documented in the treatment sheet in 385 per seven times and according of the treatment sheet the BFR ended in 40 at 10:04 AM. d. On 04/17/2025 according of the treatment sheet the patient starting the hemodialysis treatment at 6:36 AM. The BFR iniciated on 150 and the was incrised at 300 per two times then incrise at 385 per six times and ended on 200. The DFR iniiated on 150 then increase at 385 per six times and ended on 200. 3. On 04/23/2025 at 2:10 PM the RR#18 revealed a 3 hours 20 minutes dialysis treatment prescription, BFR 400 and DFR 800. Review of six “Treatment Sheet(s)” from 04/16/25 through 04/23/25, in the EMR, indicated the following: a. On 04/16/2025 - the DFR was documented 800 mL/min per 4 times during the entire treatment and no evidence of DFR, BFR and Blood Pressure at 10:05 AM appears in blank. Ended thr treatment at 11:16 AM. finalized the dialysis treatment in BFR on 200 mL/min. and DFR on 800. b. On 04/23/2025 - at 10:09 AM the BFR and DRF not registered in the dialysis treatment sheet 4. The dialysis treatments sheets of the three paients records did not provide evidence when the nurse notifies the physician related to this situations.”

“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 6 out of 19 records reviewed (RR #9, #12, #13, #14, #15, and #17). Findings include: 1. RR# 12 is a 72-year-old male admitted to the facility on 02/24/2021 with a diagnostic End Stage Renal Disease. During the record review performed on 04/23/2025 at 3:28 PM, the hemodialysis treatment three times a week for three hours and thirty minutes, Dialyzer 180 NRE Optiflux, Blood Flow Rate (BFR) of 405, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 79 kilograms (kg). a. On 04/09/2025 at 7:30 AM, pre-dialysis vitals revealed that the Blood pressure (BP) was 216/84mg/Hg. b. On 04/18/2025 at 7:58 AM, it was revealed that the BP was 194/95mg/Hg and 8:30 AM revealed that the BP was 186/mg/Hg. c. On 04/23/2025 at 7:43 AM, pre-dialysis vitals revealed that the BP was 181/88mgHg, at 8:13 AM, revealed that the BP was 189/94mg/Hg and at 8:25 AM, revealed that the BP was 187/95mg/hg. No evidence was found of nursing interventions, documentation for hypertension or notification of the physician. 2. RR# 13 is a 76-year-old male admitted to the facility on 01/27/2017 with a diagnostic End Stage Renal Disease. During the record review performed on 04/24/2025 at 3:28 PM, the hemodialysis treatment three times a week for three hours and fifteen minutes, Dialyzer 180 NRE Optiflux, Blood Flow Rate (BFR) of 380, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 64.5 kilograms (kg). a. On 04/09/2025 at 6:18 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted, at 9:03 AM, it was revealed that the BP was 139/103mg/Hg and at 9:39 AM, it was revealed that the BP was 169/107mg/Hg. b. On 04/14/2025 at 6:13 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. c. On 04/16/2025 at 6:17 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. d. On 04/21/2025 at 6:20 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. e. On 04/23/2025 at 6:13 AM, pre-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. 3. RR# 14 is an 80-year-old male admitted to the facility on 03/12/2018 with a diagnostic End Stage Renal Disease. During the record review performed on 04/24/2025 at 8:57 AM, the hemodialysis treatment three times a week for three hours and thirty minutes, Dialyzer 160 NRE Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 54.5 kilograms (kg). a. On 04/09/2025 at 6:20 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was with assistance. b. On 04/11/2025 at 6:15 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was with assistance and at 7:26 AM, it was revealed that the BP was143/118mg/Hg. c. On 04/14/2025 at 6:15 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status with assistance. d. On 04/16/2025 at 6:12 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was with assistance. e. On 04/18/2025 at 6:15 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was with assistance and at 7:07 AM, it was revealed that the BP was155/111mg/Hg. f. On 04/21/2025 at 10:06 AM, post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status with assistance. No evidence was found of nursing interventions, documentation for hypertension or notification of the physician. 4. RR# 15 is a 69-year-old male admitted to the facility on 07/09/2018 with a diagnostic End Stage Renal Disease. During the record review performed on 04/24/2015 at 9:40 AM, the hemodialysis treatment three times a week for four hours, Dialyzer 180 NRE Optiflux, Blood Flow Rate (BFR) of 385, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 87.5 kilograms (kg). a. On 04/09/2025 at 10:43 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. b. On 04/16/2025 at 10:17 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. c. On 04/18/2025 at 10:16 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was unassisted. d. On 04/21/2025 at 9:52 AM, 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. 5. RR# 17 is a 60-year-old female admitted to the facility on 06/27/2022 with a diagnostic End Stage Renal Disease. During the record review performed on 04/24/2015 at 2:00 PM, the hemodialysis treatment three times a week for four hours and five minutes, Dialyzer 200 NRE Optiflux, Blood Flow Rate (BFR) of 415, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 137 kilograms (kg). a. On 04/10/2025 at 7:18 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was with assistance. b. On 04/15/2025 at 7:06 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was with assistance. c. On 04/17/2025 at 7:16 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was with assistance and at 8:32 AM, it was revealed that the BP was152/109mg/Hg. d. On 04/19/2025 at 7:13 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was with assistance. e. On 04/22/2025 at 7:08 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was with assistance and at 9:58 AM, it was revealed that the BP was146/109mg/Hg. f. On 04/23/2025 at 7:27 AM, pre-post dialysis treatment revealed that standing Blood Pressure (BP) was not taken per nursing evaluating the patient’s ambulatory status was with assistance. No evidence was found of nursing interventions, documentation for hypertension or notification of the physician. 51637 On April 24, 2025, at 9:15AM with the clinical manager (employee #8) was evaluated the policy “Hypertension” which was published on 09/07/2021 and states: “Notify the nurse in charge if a patient has a systolic blood pressure greater than 108mm/Hg and / or diastolic blood pressure greater than 100mm/Hg.” 6.RR #9 is a 69-year-old male patient admitted on 11/29/2021 with End stage renal disease. During the record review performed on 04/23/2024 at 3:30PM, hemodialysis treatment is three times a week for 3.5 hours, Dialyzer 180NRe Optiflux, Blood Flow Rate (BFR) of 400, Dialysis Flow Rate (DFR) of Autoflow 2.0 and Patient Dry Weight (EDW) 64.5 kilogram (kg). a). On 04/16/2025 at 7:25AM it was reported that during and post the treatment the blood pressure (BP) was 202/104mm/Hg, at 8:06AM it was reported that the BP was 174/150mm/Hg, at 8:36AM it was reported that the BP was 209/102mm/Hg, at 9:06AM it was reported that the BP was 215/87mm/Hg and at 11:06AM it was reported that the BP was 128/108mm/Hg. No evidence was found of the nursing intervention or the documentation for hypertension.”

“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-records reviewed (RR) on 04/23/2025 through 04/24/2025, 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 1 out of 17 records reviewed (R.R #15). Findings include: 1. RR# 15 is a 79-year-old male admitted to the facility on 07/09/2015 with a diagnostic End Stage Renal Disease. During the record review performed on 04/23/2025 at 9:40 AM, the hemodialysis treatment three times a week for four hours, Dialyzer 180 NRE Optiflux, Blood Flow Rate (BFR) of 385, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 87.5 kilograms (kg). a. On 04/16/2025 at 10:26 AM, 11:07 AM, 7:05 AM, 11:32 AM, 12:06 PM, 12:32 PM, 1:05 PM, 1:38 PM and 2:02 PM the BFR was increased to 400. No evidence was found of the justification on the nurse note or authorized increase from the physicians”

“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 the treatment flowsheets on 04/24/2025, it was determined that facility failed to ensure that the medical records contain complete information related with reasons to not documented the standing blood pressure post the hemodialysis treatment. This deficient practice is identified in 1 out of 22 medical records reviewed. (#22). Findings include: Upon review of the facility’s policy “Patient assessment and monitoring” last update on 05/01/2023 with reference number 45284, on 04/24/2025 at 9:18AM. Policy clearly stated on the procedures that the register nurse who evaluates the patient must document the blood pressure before and after each treatment. 1.RR #22 is a 66-year-old female patient admitted on 11/07/2018. a.During the record review performed on 04/24/2025 at 8:51AM it was found that during patient hemodialysis treatment flow sheets dated 04/21/2025 and 04/23/2025 the standing blood pressure post treatment was not documented. 2.Clinical Manager (employee #8), stated in an interview on 04/24/2024 at 10:50 AM that after reviewing the medical record that did not find a rationale documented for standing blood pressure omitted. 3.The facility failed to ensure that the medical record includes pertinent information related to the patient’s individual dialysis treatment change.”