Fresenius Medical Care Dumfries

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 42929 Based on observations, interviews, and document review, it was determined the facility failed to maintain aseptic technique when conducting central venous catheter (CVC) care for one (1) of two (2) patients with a CVC. Findings: The facility’s policy titled “Central Venous Catheter (CVC) Dressing Change” dated May 6, 2024, states in part: “... Strict infection control practices and adherence to the catheter dressing change procedure is essential to prevent serious complications .... Aseptic technique must be followed to prevent infections ...” On November 18, 2024, at 12:38 AM, during the CVC care for a patient at station #2, after Staff Member #4 removed the patient’s CVC dressing, the patient’s shirt rested against the CVC exit site as the patient’s shirt was not secured away from the exit site. After Staff Member #4 cleaned the exit site, the patient’s unsecured shirt remained against the patient’s cleaned CVC exit site until the site dried and was covered with a dressing. On November 18, 2024, at 1:36 PM, the surveyor discussed the CVC cleaning observation with Staff Member #1.”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 46466 Based on interviews, and facility document review, it was determined the facility staff failed to conduct exercises to test the emergency plan annually. The findings include: On 12/19/23 at 10:00 a.m., a review of the facility’s Emergency Preparedness Plan (EPP) was conducted. The EPP included a facility-based tabletop exercise that was conducted on 1/30/23. Staff Member #1 (SM1) provided a copy of a “Regional Dialysis and Hospital Tabletop” exercise that was conducted on 11/1/22 and 11/9/22, however, the facility was not listed as one of the active participants of the exercise. SM1 stated that SM1 looked through all the facility documentation but could not find evidence of the facility staff participating. A review of the facility’s policy “Guidelines for Emergency Preparedness”, effective date 3/22/18, stated in part: “...Community Based Drill: Annually, each facility MUST participate in community-based disaster drill. If unable to participate, document who you contacted in the community and why the clinic was unable to participate...”. The findings were discussed with Staff Member #1 on 12/18/23 at 4:15 p.m. and again with Staff Members #1, #9 and #16 at the exit conference on 12/19/23 at 12:30 p.m.”

“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: 46466 Based on two (2) infection control observations and facility document review, it was determined the facility staff failed to properly perform hand hygiene when touching the dialysis machines. The findings include: On 12/18/23 at 12:05 p.m., the surveyor observed Staff Member #5 (SM5) at patient station #4. SM5 was touching the patient’s dialysis machine when the dialysis machine at station #5 began to alarm. Without removing gloves or performing hand hygiene, SM5 reached over to station #5 and touched the machine to silence the alarm. On 12/18/23 at 12:10 p.m., the surveyor observed SM5 touch the dialysis machine at station #4 without wearing gloves. A review of the facility’s policy “Personal Protective Equipment”, published 11/06/23 stated in part: “...Staff must remove gloves and wash hands after: Patient care, Exposure to blood and body fluids, Touching any surfaces within the patient station...”. The findings were discussed with Staff Member #1 on 12/18/23 at 4:15 p.m. and again with Staff Members #1, #9 and #16 at the exit conference on 12/19/23 at 12:30 p.m.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 45736 Based on observations and facility policy review, it was determined that facility staff failed to ensure that dirty items were kept away from areas designated as clean. Findings: During the flash tour on 12/18/23 at 11.45 a.m., a surveyor observed Staff Member #5 (SM5) remove their face shield from their head and place it on the clean supply cart where supplies were stored for direct patient care. In the afternoon of 12/18/23, the surveyors discussed the findings with Staff Member #1 (SM1). A policy regarding clean versus dirty areas was requested. A review of a facility policy, Dialysis Precautions, Published 01/04/2012, Version 4, was reviewed and read, in part, “...Clean Versus Dirt Areas: Clean area: An area designated for clean and unused equipment, supplies and medications. Dirty area: An area where this {sic} is a potential for contamination with blood or body fluids and area where contaminated or used supplies, equipment, blood supplies or biohazard containers are stored or handled.” During the exit conference on 12/19/23, the surveyors reviewed the finding with the following SM1, SM9 and SM16.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 46466 Based on one (1) infection control observation and facility document review, it was determined that the facility staff failed to properly clean and disinfect the dialysis station. The findings included: On 12/18/23 at 11:15 a.m., Staff Member #5 (SM5) was observed disinfecting patient station #15. SM5 did not fold down the chair side tables to disinfect, did not recline the chair, and disinfect within the crease of the chair and did not clean the blood pressure cuff. A review of the facility’s policy “Cleaning and Disinfecting the Dialysis Station”, published 9/5/23, stated in part: “...Definition, Dialysis Station: Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment, patient training, and/or patient clinic visits. Equipment in the dialysis station may include (but is not limited to) the following: - Dialysis machine/cycler and attachments such as IV pole, BP cut and hand sanitizer/holder, organizer. - Chair/bed. - Pureflow SL...”. The findings were discussed with Staff Member #1 on 12/18/23 at 4:15 p.m. and again with Staff Members #1, #9 and #16 at the exit conference on 12/19/23 at 12:30 p.m.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 45736 Based on observations and facility policy review, it was determined that facility staff failed to properly discard of a multi dose vial after 28 days of opening. Findings: During the flash tour on 12/18/23 at 10:30 a.m., a surveyor discovered an opened multi dose vial of Turbesol (used for tuberculosis skin testing of patients and staff) in the refrigerator with a opened date of 11/5/23. These items must be discarded after 28 days from opening. The date of discard should have been 12/3/23. In the afternoon of 12/18/23, the surveyors discussed the findings with Staff Member #1 (SM1). A policy regarding expired multi dose vials was requested. A review of the facility’s policy titled, Medication Preparation and Administration, Published 02/06/2023, Version 9, was conducted and read, in part: “...Monitoring Expired Medications...Any open multi dose vials must be discarded 28 days after opening or per manufacturer’s expiration date.” During the exit conference on 12/19/23, the surveyors reviewed the finding with the following SM1, SM9 and SM16.”

“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: 45736 Based on observations and facility document review, it was determined the facility failed to maintain a safe environment for dialysis patients and staff by not locking the supply room door. Findings: On 12/18/23 at 10:30 a.m., the surveyor observed the door to the supply room was propped open. There was a sign on the door that stated that the door must remain closed at all times. This door remained open until Staff Member #4 (SM4) closed the door on 12/18/23 at 11:47 a.m. In the afternoon of 12/18/23, the surveyors discussed the findings with Staff Member #1 (SM1). A policy regarding facility access and storage room doors was requested. A review of the facility’s policy titled, Physical Security and Facility Access, Published 09/05/2023, Version 3, was conducted and read, in part: “...Physical Security...All supply storage rooms are the limited to authorized persons only unless egress through the area is necessary for emergency evacuation of the facility.” During the exit conference on 12/19/23, the surveyors reviewed the finding with the following SM1, SM9 and SM16. 46466 49355 Based on observations, interview and document review, it was determined the facility staff failed to ensure it maintained a safe environment. Specifically, the facility staff failed to dispose of contaminated sharps at the point of use in two (2) out of two (2) observations when staff members where discontinuing dialysis treatments for patients with a fistula or graft. Findings: On 12/18/2023 at 11:35 a.m. at station #3, the surveyor observed staff member (SM) 5 remove the needles from a patient’s arteriovenous (AV) fistula and place the needles on the chairside table, and then later placed them in the sharps container. On 12/18/2023 at 1:10 p.m. at station #11, the surveyors observed SM7 remove the needles for a patient’s AV fistula and place the needles on the chairside table, and then later placed them in the sharps container. An interview with SM1 on 12/19/2023 at 12:05 p.m. confirmed the facility’s expectation that all contaminated sharps will be placed immediately into a sharps container once removed from a patient. A review of the facility’s policy titled “General Cleanliness and Infection Control Guidelines”, published 2//7/22, showed, in part: “Contaminated Needles and Sharps Container ... Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are: ... Clearly identifiable as a sharp’s container ... Designed to close ... Puncture resistant ... Leak proof on the sides and bottom ... Labeled in accordance with OSHA Bloodborne Standard 1910.1030 ... Designed to prevent anyone from reaching into the containers.” The above concern was discussed with SM 1, 9 and 16 at the exit conference on 12/19/2023 at 4:15 p.m.”

“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: 45736 Based on clinical records review, facility document review and interview, it was determined the facility staff failed to follow physician’s orders for the prescribed DFR (dialysate flow rate) for two (2) of four (4) in-center dialysis patients included in the sample. Patient #2 (Pt2) and Patient #7 (Pt7) The findings included: Pt2: The surveyor reviewed six (6) dialysis treatment records from 12/4/23 through 12/15/23 Four (4) of six (6) treatment records for Pt2 evidenced an order for DFR of 600. The treatment sheets evidenced the following: On 12/4/23 the final average treatment DFR was documented as 800. On 12/11/23 the final average treatment DFR was documented as 800. On 12/13/23 the final average treatment DFR was documented as 800. On 12/15/23 the final average treatment DFR was documented as 800. Pt2’s clinical record failed to contain evidence of documentation explaining why the DFR was not being administered as prescribed and/or notification to the charge nurse regarding an alteration in DFR. Pt7: The surveyor reviewed six (6) dialysis treatment records from 12/1/23 through 12/13/23. Four (4) of six (6) treatment records for Pt7 evidenced an order for DFR of 700. The treatment sheets evidenced the following: On 12/6/23 the final average treatment DFR was documented as 800. On 12/8/23 the final average treatment DFR was documented as 800. On 12/11/23 the final average treatment DFR was documented as 800. On 12/13/23 the final average treatment DFR was documented as 800. Pt7’s clinical record failed to contain evidence of documentation explaining why the DFR was not being administered as prescribed and/or notification to the charge nurse regarding an alteration in DFR. In the afternoon of 12/18/23, the surveyors discussed the findings with Staff Member #1 (SM1). A policy regarding alterations in DFR was requested. A review of the facility’s policy titled, Patient Assessment and Monitoring, Published 05/01/2023, Version 4, was conducted and read, in part: “...During Treatment...3. Machine Parameters and Extracorporeal Circuit: Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow rate. Check dialysate flow rate setting is correct and the prescribed flow is being delivered.” In an interview with SM1 on 12/19/23 at approximately 4:00 p.m., when asked about the expectation in documentation of an alteration in the prescribed DFR, SM1 told the surveyor that although the policy does not state an alteration in DFR must be documented, like it does for blood flow, it is the expectation at this facility that any alteration in the DFR, the patient care technician will alert the nurse and the nurse will then document in the chart the reason for the alteration. During the exit conference on 12/19/23, the surveyors reviewed the finding with the following SM1, SM9 and SM16.”