Fmc - Georgetown Dialysis Clinic

“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: 35949 Based on observation, interview, and review of the facility’s policy, it was determined the facility failed to ensure one (1) of two (2) staff members observed, Registered Nurse (RN) #4, performed hand hygiene as required. Failure to perform hand hygiene provided a mode of cross contamination with the potential spread of pathogens, which could negatively impact the health and well-being of the forty-nine (49) patients receiving dialysis treatments and/or home therapy oversight at the facility. The findings include: Review of the facility’s policy titled, “Hand Hygiene,” with a published date of 11/06/2023, stated that immediately after removing gloves and/or when entering and leaving the treatment area, hands were to be “decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water.” Observation of the dialysis treatment area on 11/15/2023 at 9:56 AM with Facility Administrator #1 and Facility Administrator #2, revealed RN #4 wore a pair of gloves while in Station #8. Per the observation, RN #4 exited Station #8 and removed the pair of gloves as well as a face shield and gown. RN #4 then exited the treatment area. Further observation revealed RN #4 failed to perform hand hygiene after removing gloves and prior to leaving the treatment area. During an interview on 11/15/2023 at 10:00 AM, Facility Administrator #1 and Facility Administrator #2 confirmed staff members were expected to perform hand hygiene after removing gloves.”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 35949 Based on observation, interview, review of the manufacturer’s directions for use (DFU), and review of the facility’s policy and procedure, it was determined the facility failed to prevent inaccurate arterial and venous pressure readings and possible blood contamination by not immediately removing an external transducer protector when wetted with blood or other fluid. The facility failed to inspect the machine side of a wetted external transducer protector for visible fluid and/or blood during one (1) of one (1) observation at Station #4. Failure to immediately remove a wetted external transducer protector and inspect the machine side for contamination created the potential for inaccurate pressure readings and possible contamination of the dialysis machines’ transducer component, which could expose the forty-four (44) in-center hemodialysis patients to bloodborne pathogens. The findings include: Review of the facility’s policy and procedure titled, “Maintenance of Transducer Protectors Procedure,” published 11/01/2021, indicated, “External transducer protectors must be changed immediately when they become wet with blood or other fluid. Wet external transducer protectors must be thoroughly examined to determine if any blood or other fluid contamination is visible on the machine side (back) of the transducer protector prior to replacement. If no evidence of blood or fluid contamination is evident, no further action is required other than replacing the wet transducer. If the machine side (back) of the external transducer protector shows evidence of contamination with blood or other fluid; [sic] the machine must not be used to dialyze another patient until it has been thoroughly examined for any internal evidence of blood or fluid contamination by Technical Services. Do not reuse external transducer protectors.” Review of an undated manufacturer’s DFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors” under “Instructions for Use,” indicated, “If fluid is visible on the side of the TP [transducer protector] that faces the machine, have qualified personnel open the machine and check for contamination after the treatment is completed. If contamination has occurred, the machine must be taken out of service and disinfected before further use according to manufacturer recommendations.” Observation on 11/15/2023 from 9:45 AM until 10:10 AM with Facility Administrator #1 and Facility Administrator #2, revealed a wetted external TP of the dialysis machine located at Station #4. Further observation revealed Patient Care Technician (PCT) #8 was notified of the finding at 10:10 AM. PCT #8 then removed the wetted external TP from the dialysis machine located at Station #4. Additional observation revealed PCT #8 failed to observe the machine side of the wetted external TP after removal. During an interview on 11/15/2023 at 10:15 AM, PCT #8 stated staff was not aware of the wetted transducer protector at Station #4 and did not visualize the machine side of the transducer protector prior to discarding.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 35949 Based on observation, interview, and review of the facility’s policy, it was determined the facility failed to restrict access to the water purification and storage system to only individuals responsible for monitoring and maintenance of the system for one (1) of one (1) water purification and storage system. Failure to restrict access to the water purification and storage system necessary for dialysis to only individuals responsible for monitoring and maintenance of the system had the potential to negatively impact the safety and well-being of the forty-four (44) in-center hemodialysis patients receiving treatments at this facility. The findings include: Review of the facility’s policy titled, “Physical Security and Facility Access,” with a published date of 09/05/2023, indicated, “Restricted access must be maintained to prevent unwanted tampering with the water treatment equipment. The facility must be maintained to prevent unwanted entry by outside persons not involved in the daily operation of the clinic. This is accomplished by: Locking all doors that allow access to the water treatment equipment.” Observation on 11/16/2023 at 8:35 AM with Facility Administrator #1, the outgoing Administrator, and Facility Administrator #2 revealed the door from the treatment area to the room where the water purification and storage system was located lacked a locking mechanism restricting access from the treatment area. In addition, the code on the door from a hallway to the water room was coded the same as home therapy and office doors. Facility Administrators #1 and #2 confirmed the water purification and storage system was not restricted to authorized personnel only. During an interview on 11/16/2023 at 8:29 AM, Facility Administrator #2, the incoming Administrator, confirmed facility housekeeping staff cleaned the unit “after hours” around 5:00 PM after facility staff left for the day, noting housekeeping staff had unrestricted access to the water purification and storage system.”

“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: 35949 Based on observation, interview, review of the manufacturer’s directions for use (DFU), and review of the facility’s policy and procedure, it was determined the facility failed to follow the bloodline manufacturer’s DFU during dialysis treatments by not maintaining the arterial drip chamber fluid levels at 85% to 95% full and the venous drip chamber fluid levels at 65% to 75% full during four (4) of four (4) observations. Failure to follow the bloodline manufacturer’s DFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the forty-four (44) patients receiving in-center hemodialysis treatments in this facility. The findings include: Review of the facility’s policy and procedure titled, “Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer,” with a published date of 07/06/2021, indicated under a “Final Machine Verification” section, “Prior to starting the blood pump, verify the following: 1. All connections are secure. 2) Dialysate lines are attached properly to the dialyzer. 3. There is at least 300 ml [milliliters] of saline in the saline bag and the saline line is double clamped. 4. Any unused administration lines are clamped. 5. The arterial chamber is 85-95% full, and venous chamber is 65-75% full. 6. Arterial and venous monitoring transducers are securely connected, not wet with saline, and the transducer clamps are open. 8. Venous drip chamber is correctly positioned in its housing and venous bloodline is threaded through venous occluding clamp. 9. No kinks or bends are evident in any of the tubing. 10. No air is noted in the dialyzer or bloodlines.” Review of a manufacturer’s DFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors,” undated, indicated, “2. During Treatment; a. Periodically check the extracorporeal circuit for any evidence of possible Separation [sic] or leaks. b. Maintain fluid level in pre-pump arterial chamber at 85 to 95% full, post-pump arterial and venous chambers at 65 to 75% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air Leaks [sic] will also cause the chamber levels to fluctuate.” 1. Observations of the hemodialysis treatment area on 11/13/2023 revealed the following: a. At 9:15 AM, the arterial drip chamber fluid levels were less than (<) 85% full in Station #11 and #16. The venous drip chamber fluid levels were greater than (>) 75% full in Station #1, #3, #5, #6, #7, #8, #11, #12, and #16. b. At 9:30 AM, the arterial drip chamber fluid levels were < 85% full in Station #1, #5, #10, #11, #16, and #17. The venous drip chamber fluid levels were > 75% full in Station #1, #3, #5, #6, #7, #10, #11, #12, #16, and #17. 2. Observations of the hemodialysis treatment area on 11/15/2023 with Facility Administrator #1 and Facility Administrator #2 revealed the following: At 9:50 AM and again at 10:00 AM, the arterial drip chamber fluid levels were < 85% full in Station #1, #3, and #6. The venous drip chamber fluid levels were > 75% full in Station #1, #3, #4, #6, #10, #12, #14, #16, and #17. During an interview on 11/15/2023 at 10:00 AM in the treatment area, Facility Administrator #1 and Facility Administrator #2 reviewed the manufacturer’s DFU and acknowledged the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU.”

“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: 35949 Based on interview, record review, and review of the facility’s policy, it was determined the facility failed to follow the individualized dialysis prescription as ordered by the medical provider for one (1) of five (5) sampled patients, Patient #2. Failure to follow the medical provider’s dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the forty-nine (49) patients receiving dialysis treatments and/or home therapy oversight at this facility. The findings include: Review of the facility’s policy titled, “Unable to Achieve Prescribed Blood Flow Rate,” published on 11/01/2021, stated, “Document in patient’s treatment record what action taken to address the inadequate blood flow and if unable to resolve. The nurse shall document any physician orders.” Review of Patient #2’s clinical record revealed the resident was admitted by the facility on 01/12/2023 with a diagnosis of end stage renal disease (ESRD). Review of Patient #2’s “Orders Summary Report”, undated but created 11/14/2023, and “Patient Transfer” Report, undated but created on 11/14/2023, revealed a prescribed blood flow rate (BFR) of 425 milliliters per minute (mL/min). Review of five (5) of ten (10) electronic “Treatment Sheet for Facility: [Name of Facility]” from 10/24/2023 through 11/14/2023, indicated the following: a. on 10/25/2023, the BFR was documented at 400 mL/min from 11:20 AM until the treatment was terminated at 3:27 PM; b. on 10/27/2023, the BFR was documented at 400 mL/min during the entire treatment; c. on 11/01/2023, the BFR was documented at 450 mL/min from 3:02 PM until the treatment was terminated at 3:40 PM; d. on 11/03/2023, the BFR was documented at 400 mL/min from 11:09 AM until 1:07 PM; and e. on 11/10/2023, the BFR was documented at 400 mL/min during the entire treatment. There was no documented reason for the change from the prescribed BFR. During an interview on 11/15/2023 at 8:20 AM, Facility Administrator #2 confirmed Patient #2’s treatment sheets lacked documentation regarding why changes to the patient’s prescribed BFR occurred.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 35949 Based on record review, interview, and review of the facility’s policy, it was determined the facility failed to complete an initial comprehensive assessment conducted by all members of the interdisciplinary team (IDT - a registered nurse [RN], a physician treating the patient for end stage renal disease, a social worker [SW], and a registered dietitian [RD]) within thirty (30) calendar days or thirteen (13) hemodialysis treatment sessions after admission, for one (1) of two (2) sampled patients new to dialysis and admitted to the facility within the last ninety (90) days, Patient #1. This failure allowed potential areas of concern not to be identified and left unaddressed related to the patients’ plans of care and had the potential to negatively impact the care and wellbeing of the forty-nine (49) patients receiving dialysis treatments and/or home therapy oversight at this facility. The findings include: Review of the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” with a published date of 07/03/2023, stated, “An initial comprehensive interdisciplinary assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the later [sic] of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. Patients changing modality are classified as new patients and must have comprehensive interdisciplinary assessments and plans of care completed with the same frequency as patients new to dialysis.” Review of Patient #1’s “Patient Transfer” report revealed an admission date of 09/29/2023 and a diagnosis of end state renal disease (ESRD). Review of Patient #1’s electronic medical record revealed no CIA completed by the SW as a member of the IDT within thirty (30) days or thirteen (13) treatment sessions from the admission date. During an interview on 11/14/2023 at 9:38 AM, Facility Administrator #2 confirmed a CIA was not completed by the SW as a member of the IDT within thirty (30) days or thirteen (13) treatments from the admission date for Patient #1. Facility Administrator #2 stated the SW had reportedly made attempts to contact Patient #1. During an interview on 11/14/2023 at 10:31 AM, Facility Administrator #1 stated the RD created a list of patients needing CIAs and distributed the list via email. Facility Administrator #1 stated Patient #1 had changed shifts and treatment days and was “missed” by the SW. During an interview on 11/15/2023 at 9:17 AM, Patient #1 stated the SW had met with him/her after admission to the facility and had “covered” everything. During an interview on 11/15/2023 at 11:45 AM, the RD stated Patient #1 was on an emailed list for CIAs, but stated Patient #1 was missed by the SW. During an interview on 11/15/2023 at 12:00 PM, the SW stated they had received the emailed list for CIAs, but noted Patient #1 worked full time, did not answer the phone, and had changed treatment days and shifts. The SW stated their respective schedules had “crisscrossed”, and the CIA was not completed within thirty (30) days or thirteen (13) treatment sessions from the date of admission. The SW stated they met with Patient #1 for an introductory contact, but the contact was not documented.”