Fmc San German

“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 03/11/2025, it was determined that the facility failed to monitor the environment to ensure its sanitation and reduce the potential transmission of infectious agents within and between units, due to the lack of adherence to “standard precautions”. Failed to ensure that the garbage can did not come into contact with the dialysis machines which poses risk of “cross contamination”. Findings include: During the observations made in the treatment area in the company of the Supervisor employee #1, the following was observed: 1. On 03/11/2025 at 8:58 AM, the trash cans were observed touching parts of the dialysis machine at stations #12, # 14, #16, # 21, and #28 during dialysis treatment. 2. On 03/11/2025 at 9:06 AM, three (3) Clear Guard Caps expired on 10/19/2024 and were observed on the island located at stations #9 and #10. 3. On 03/11/2025 at 9:12 AM, one (1) Twinpack Hemodialysis Fistula Needle Sets size #15 expired 11/30/2024 and four (4) Clear Guard Cap expired 10/14/2024 were observed on the island located at station #25. 4. On 03/11/2024 at 9:24 AM, one (1) Clear Guard Caps expired on 10/14/2024 and were observed on the island located at stations #20. 5. On 03/11/2025 at 9:28 AM, one (1) Twinpack Hemodialysis Fistula Needle Sets size #15 expired 11/30/2024 and were observed on the island located at stations #14 and #15. 6. On 03/11/2025 at 10:14 AM, one (1) opened vial dated 03/19/2024 was observed, according to the manufacturer, once opened the vial should be discarded after 42 days. 7. On 03/11/2025 at 10:18 AM, one (1) N95 Particulate Respirator box of twenty (20) masks seventeen (17) masks were found expired 03/09/2025. 8. On 03/11/2025 at 10:32 AM, one (1) double pack of hemodialysis fistula needles #16 expired 10/31/2024, one (1) double pack of hemodialysis fistula needles #15 expired 11/30/2024 and seventeen (17) sets of A.V. fistula safety needles #14 expired 07/02/2024 were found in the sink drawers between stalls #18 and #19. 9. On 03/11/2024 at 10:40 AM, was observed inside the drawers of the unit’s islands with a lack of cleanliness.”

“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: 47632 Based on observations made in the treatment area on the second shift on 03/11/2025, it was determined that the facility did not ensure that staff washed their hands and then put on disposable gloves when touching patients’ equipment at the dialysis station. Findings include: During the observations made in the treatment area in the second shift, the following were observed: 1. On 03/11/2025 at 12:51 PM, Supervisory employee #1 was observed touching the dialysis machine in station #11 without washing his hands or glove hands.”

“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: 47384 Based on observations made in the treatment area on 03/11/2025, it was determined that the facility failed to mantain the dialysis clean and disinfected. Findings include: During observation of the treatment area, three (3) patients were observed having personal belongings either hanging from or on top of the folding table of the treatment chairs.”

“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 treatment area on 03/11/2025, 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: During the observations made in the treatment area, the following were observed: 1. On 03/11/2025 at 9:16 AM, 4 out of 4-unit islands observed without brakes. 2. On 03/11/2025 at 9:24 AM, it was observed that one (1) drawer is missing from the island located at station #20. 3. On 03/11/2025 at 10:22 AM, peeling paint was observed in the hand wash at station #3. 4. On 03/11/2025 at 12:17 AM, dark spots were observed on the ground at stations # 10, # 11, # 21 and # 24. 47384 5. On 03/12/2025 at approximately at 9:05 AM, it was observed that the dirty sink faucet had green corrosion stains. 6. On 03/12/2025 at approximately at 9:05 AM, it was observed that the clean sink drain had brown rust like stains..”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 47384 Based on observations made in the treatment area on 03/11/2025, 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: During the review of the preventive maintenance documentation for dialysis machines, it was observed that three of the machines inspected showed a difference in the sequence of working hours reported in the system. Machines identified: 4TOS-276935 4TOS-276942 4TOS-276995”

“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 03/11/2025, 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 shift at patients’ stations #1, #9, #11, #15, and #17. This deficient effect 5 out of 7 patients observed receiving treatment. Findings include: During the observations made in the treatment area on 03/11/2025 at 8:30 AM through 1:00 PM, the following were found: 1. On 03/11/2025 at 8:45 AM, the patient was located on station # 9, it was observed that the vascular access was covered with sheets. 2. On 03/11/2025 at 8:48 AM, the patient was located on station # 1, it was observed that the vascular access was covered with sheets. 3. On 03/11/2025 at 8:50 AM, the patient was located on station # 11, it was observed that the vascular access was covered with sheets. 4. On 03/11/2025 at 8:53 AM, the patient was located on station # 15, it was observed that the vascular access was covered with sheets. 5. On 03/11/2025 at 8:57 AM, the patient was located on station # 17, 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.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 47384 Based on observations made of the treatment area, during the first shift and second shift of 03/12/2025 from 8:30 AM through 3:00 PM, it was determined that the facility failed to maintain Life Safety measures that complies with NFPA 101 (Life Safety Code), NFPA 99 (Health Care Facilities Code), which could affect all patients receiving treatment and staff. Findings include: 1. Penetrations were observed in the dividing wall of the dialysis treatment unit and the unit’s waiting area. 2) Based on interview and visual inspection there was no documentation provided regarding the sprinkler piping internal inspection, pressure gauges on the sprinkler main were replaced or tested by comparison with a calibrated gage within the last five years. Date observed on gauges was June 2014.”

“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: 20423 Based on fourteen 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 6 out of 14 records reviewed (RR #2, #6, #9, #10, #11 and #12). Findings include: During the flowsheet review performed on 03/11/2025 and 03/12/2025 at 9:00 AM to 3:30 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 03/11/2025 at 1:30 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 #2 is a 43-year-old male patient admitted to the facility on 02/10/2017 with diagnosis of End Stage Renal Disease (ESRD). During the record review performed on 03/11/2025 at 12:38 PM, it was found that patients have hemodialysis treatment three a week for 4 hours, Blood Flow Rate (BFR) of 375, Dialysis Flow Rate (DFR) of Manual 800, Dialyzer with 180 NRe Optiflux and patient EDW 75 kilogram (kg). a.On 03/04/2025 at 8:35 AM it was revealed that the Blood Pressure (BP) was 166/103 mm/Hg, at 9:34 AM revealed that the BP was 186/118 mm/Hg, at 10:07 AM revealed that the BP was 167/101 mm/Hg, at 10:25 AM revealed that the BP was 183/100 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 03/06/2025 at 7:33 AM it was revealed that the BP was 88/50 mm/Hg, at 9:07 AM revealed that the BP was 75/41 mm/Hg, at 9:30 AM revealed that the BP was 85/52 mm/Hg. No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify high blood pressure. Interview with the Clinical Manager nurse employee #2 on 03/11/2025 at 1:00 PM refer that did not find other nurse documentation related to management of patient blood Pressure during the treatments. 2. RR #6 is a 73-year-old female patient admitted to the facility on 05/23/2023 with diagnosis of ESRD. During the record review performed on 03/12/2025 at 2:50 PM, it was found that patients have hemodialysis treatment three a week for 3.5 hours, BFR of 325, DFR of Manual 800, Dialyzer with 180 NRe Optiflux and patient EDW 88.5 kg. a. On 02/27/2025 at 11:12 AM revealed that the BP was 198/96 mm/Hg, at 11:39 AM revealed that the BP was 210/99 mm/Hg, at 13:49 AM revealed that the BP was 192/94 mm/Hg, at 14:03 PM revealed that the BP was 192/96 mm/Hg, at 14:11 PM revealed that the BP was 200/105 mm/Hg. No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify high blood pressure. b. On 03/01/2025 at 11:20 AM revealed that the BP was 190/86 mm/Hg, at 11:26 AM revealed that the BP was 187/92 mm/Hg, at 13:54 AM revealed that the BP was 98/74 mm/Hg. No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identifying high blood pressure and low blood pressure. c. On 03/06/2025 at 11:25 AM revealed that the BP was 127/100 mm/Hg, at 11:33 AM revealed that the BP was 164/104 mm/Hg. No evidence was found of the nurse intervention or documentation performed by personnel of patient’s assessment when identify high blood pressure. Interview with the Clinical Manager nurse employee #2 on 03/12/2025 at 3:30 PM refer that has not find other nurse documentation related to management of patient blood Pressure during the treatments. 47632 3. R.R #9 is a 79-year-old female admitted to the facility on 02/04/2025 with a diagnostic End Stage Renal Disease. During the record review performed on 03/12/2025 at 8:25 AM, the hemodialysis treatment three a week for four hours, Dializaer 160 NRE Optiflux, Blood Flow Rate (BFR) of 325, Dialysis Flow Rate (DFR) of 600 and Patient Dry Weight (EDW) of 62.5 kilograms (kg). a. On 02/27/2025 at 4:16 PM, in the evaluation of vitals in pre dialysis it was revealed that the Blood Pressure (BP) was 192/69mg/Hg, at 5:02 PM during the treatment revealed that the BP was 182/79 mg/Hg, at 5:04 PM revealed that the BP was 199/71 mg/Hg, at 6:05 PM revealed that the BP was 182/86 mg/Hg, at 6:37 PM revealed that the BP was 199/85 mg/Hg, at 7:02 PM revealed that the BP was 195/84 mg/Hg, and at 8:00 PM revealed that the BP was 186/79 mg/Hg. No evidence of vital signs taken from 7:02 PM to 8:02 PM by the nursing staff. No evidence was found of nursing interventions or documentation for hypertension. b. On 03/04/2025 at 5:27 PM, it was revealed that the BP was 195/80 mg/Hg, 5:31 PM revealed that the BP was 190/81 mg/Hg, at 6:35 PM revealed that the BP was 184/87 mg/Hg, at 7:03 PM revealed that the BP was 197/87 mg/Hg, and at 8:05 PM revealed that the BP was 198/88 mg/Hg. No evidence of vital signs taken from 8:32 PM to 9:25 PM by the nursing staff. No evidence was found of nursing interventions or documentation for hypertension. 4. R.R #10 is a 72-year-old male admitted to the facility on 02/23/2021 with a diagnostic End Stage Renal Disease. During the record review performed on 03/12/2025 at 9:29 AM, the hemodialysis treatment three a week for four hours, Dializaer 180 NRE Optiflux, Blood Flow Rate (BFR) of 375, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 85.5 kilograms (kg). a. On 02/24/2025 at 10:14 AM, pre-dialysis vitals assessment revealed that standing Blood Pressure (BP) was not taken per nursing evaluation the patient ambulatory status was unassisted. b. On 02/28/2025 at 10:30 AM, pre- and post-dialysis assessment of vitals revealed that standing Blood Pressure (BP) was not taken per nursing evaluation and the patient ambulatory status was unassisted. c. On 03/03/2025 at 10:20 AM, pre- and post-dialysis assessment of vitals revealed that standing Blood Pressure (BP) was not taken per nursing evaluation and the patient ambulatory status was unassisted. d. On 03/05/2025 at 10:02 AM, pre-dialysis vitals assessment revealed that standing Blood Pressure (BP) was not taken per nursing evaluation the patient ambulatory status was unassisted. 5. R.R #11 is a 79-year-old female admitted to the facility on 12/05/2015 with a diagnostic End Stage Renal Disease. During the record review performed on 03/12/2025 at 10:42 AM, the hemodialysis treatment three a week for three hours and thirty minutes, Dializaer 160 NRE Optiflux, Blood Flow Rate (BFR) of 350, Dialysis Flow Rate (DFR) of 500 and Patient Dry Weight (EDW) of 52 kilograms (kg). a. On 02/25/2025 it was revealed that there is no evidence that the nursing staff took vital signs between 11:59 AM and 1:00 PM hours. b. On 02/27/2025 it was revealed that there is no evidence that the nursing staff took vital signs between 11:50 AM and 12:43 PM hours. c. On 03/04/2025 it was revealed that there is no evidence that the nursing staff took vital signs between 11:59 AM and 1:00 PM hours. d. On 03/06/2025 it was revealed that there is no evidence that the nursing staff took vital signs between 2:02 PM and 2:51 PM hours. 6. R.R #12 is a 67-year-old female admitted to the facility on 03/27/2018 with a diagnostic End Stage Renal Disease. During the record review performed on 03/11/2025 at 2:40 PM, the hemodialysis treatment three a week for three hours and thirty minutes, Dializaer 180 NRE Optiflux, Blood Flow Rate (BFR) of 375, Dialysis Flow Rate (DFR) of 800 and Patient Dry Weight (EDW) of 65 kilograms (kg). a. On 03/08/2025 at 5:55 PM, it was revealed that the BP was 190/68 mg/Hg, and 8:01 PM revealed that the BP was 132/109 mg/Hg. b. On 03/10/2025 at 1:33 PM, it was revealed that the BP was 187/71 mg/Hg, 1:38 PM revealed that the BP was 188/69 mg/Hg, and at 3:05 PM revealed that the BP was 187/75 mg/Hg. No evidence was found of nursing interventions or 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 review of the treatment flowsheets on 03/11/2025 at 11:00 AM till 3:30 PM and on 03/12/2025 from 9:00 till 3:00 PM, it was identified that the facility failed to follow physicians’ orders in the blood flow (BFR) and dialysate flow rate (DFR) during the dialysis treatment and documented their intervention in the management of the patients BFR and DFR. This deficient practice is identified in 1 out of 14 records reviewed (RR #9). Findings include: Upon review of the facility’s policy # 45284 Patient assessment and monitoring last update on 05/01/2023, on 03/11/2025 at 1:30 PM. Policy clearly stated that during dialysis; personnel in charge must ensure prescribed blood flow (BFR) and dialysate flow rate (DFR) follows physician prescription throughout the treatment. 1. R.R #9 is a 79-year-old female admitted to the facility on 02/04/2025 with a diagnostic End Stage Renal Disease. During the record review performed on 03/12/2025 at 8:25 AM, the hemodialysis treatment three a week for four hours, Dializaer 160 NRE Optiflux, Blood Flow Rate (BFR) of 325, Dialysis Flow Rate (DFR) of 600 and Patient Dry Weight (EDW) of 62.5 kilograms (kg). a. On 02/22/2025 at 5:10 PM, 5:12 PM, 5:32 PM, 6:00 PM, 6:34 PM, 7:03 PM, 7:32 PM, 8:03 PM, 8:35 PM, and 9:09 PM the DFR was decreased to 500. No evidence was found of the justification on the nurse note or authorized decrease from the physicians”