Fresenius Medical Care Sumter

“EP Program Patient Population CFR(s): §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: [“Persons at risk” does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This Standard is not met as evidenced by: 36779 Based on review of the facility’s Emergency Preparedness Program and interview, the facility failed to review and update the EPP every two years. The findings: Review of the facility’s EPP dated 2017 and review of the Governing Body Meeting Minutes for 2023 on 11/8/23 at 11:00 AM revealed there was no documented evidence the facility’s EPP was reviewed or updated since 2027. During an interview with the Clinic Manager (CM) on 11/8/23 at 3:30 PM, she/he reviewed the facility’s documentation and confirmed the findings.”

“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: 28883 Based on observations, interviews, and review of the facility’s policy, titled, “Hand Hygiene”, one of two Registered Nurses (RN) and one of two Patient Care Technicians (PCT) observed discontinuing a dialysis treatment failed to ensure patients performed hand hygiene after dialysis treatment and prior to exiting the dialysis treatment room. (Registered Nurse (RN) #1 and Patient Care Technician (PCT) #2) The findings included: Observations on 11/6/23 at 2:40 PM revealed Patient Care Technician #2 removing the second needle from a patient at dialysis machine #12 in dialysis station #20. PCT #2 folded gauze over the site. The patient held pressure over the site with a gloved hand. Blood seeped through the gauze onto the Chux and the arm rest of the chair, onto the sides of the chair, and on the floor. PCT #2 changed the gauze and taped the patient’s needle site after it stopped bleeding. The patient removed his/her glove. PCT #2 accompanied the patient to the scale. PCT #2 did not ask the patient to perform hand hygiene after removing the glove. The patient exited the dialysis treatment room without performing hand hygiene. Observations on 11/7/23 at 9:45 AM revealed a patient at dialysis machine #40 in dialysis station #11 holding the needle site with gauze using a gloved left hand to stop the bleeding. At 9:55 AM, the patient’s needle site was taped up. The patient was getting an injection in his/her arm before leaving. The patient removed the soiled glove from the left hand, weighed at the scale, and exited the dialysis treatment room. The patient was not asked and did not perform hand hygiene before exiting. The finding was verified by Registered Nurse #1 on 11/7/23 at 9:58 AM. RN #1 administered the injection and was present when the patient weighed and left the dialysis treatment room. On 11/7/23 at 12:10 PM, review of the facility policy provided by the dialysis clinic, entitled, “Hand Hygiene”, revealed, “All staff, patients, patient care givers,...must follow the same requirements for hand hygiene...Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water When...Entering and leaving the treatment area...Immediately after removing gloves. After contact with body fluids...”.”

“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: 36779 Based on observations, interviews, and review of the facility’s policies, the facility failed to ensure staff washed hands between patients for one of two Patient Care Technicians (PCT) observed. (PCT #1) The findings are: On 11/6/23 at 3:37 PM, PCT #1 was observed providing patient care to the patient in dialysis station #1. PCT #1 cleaned the blood from the left upper arm of the patient in dialysis machine #4, discarded the bloody disposable barrier sheet in the nearby trash can, and applied pressure to the patient’s left upper arm dialysis access site. PCT #1 removed the soiled gloves and applied clean gloves without performing hand hygiene. PCT #1 went to the patient in Dialysis station #9 and provided care to the patient’s left upper arm dialysis access site. PCT #1 applied clean gloves, removed her/his disposable gown, removed the gloves and applied clean gloves without performing hand hygiene. PCT #1 went to the patient in dialysis Chair #2 and taped the left upper arm site, removed the soiled dressing, and applied gauze and held it. In an interview with PCT #1 at 4:10 PM, he/she confirmed providing care to multiple patients involving touching blood without performing hand hygiene in between patients. PCT #1 stated, “Ya, I usually do.” (perform hand hygiene) 28883 On 11/7/23 at 12:10 PM, review of the policy provided by the dialysis clinic, entitled, “Hand Hyiene”, revealed, “hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water Before and after direct contact with patients,..Immediately after removing gloves, After contact with body fluids or excretion, mucous membranes, non-intact skin,...After contact with inanimate objects near the patient...”.”

“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: 28883 Based on observations, interview, and review of the facility policy, “Cleaning and Disinfecting the Dialysis Station”, 2 of 2 Patient Care Technicians (PCT) observed cleaning/disinfecting dialysis machines, chairs, and equipment, failed to ensure contaminated equipment/floor had been cleaned and/or disinfected appropriately after contamination. (PCT #2) The findings included: Observations on 11/6/23 at 2:40 PM revealed Patient Care Technician #2 removing the second needle from a patient at dialysis machine #12 in dialysis station #20. PCT #2 folded gauze over the site and the patient held pressure with a gloved hand. Blood seeped through the gauze and onto the Chux onto the arm rest of the chair, onto the sides of the chair, and on the floor. At 2:52 PM, PCT #2 was observed to use a 1:100 bleach rag to clean up gross blood spill from the side of the chair, the arm rest, and the floor. PCT #2 failed to use a second bleach rag to disinfect or clean the surface of the chair or the floor after the gross blood had been removed. Observations on 11/6/23 at 2:58 PM revealed Patient Care Technician #2 cleaning the dialysis machine. PCT #2 emptied the prime rinse bucket of saline but did not clean the inside or outside of the prime rinse container with disinfectant before hanging it back onto the dialysis machine. The above findings were reviewed with and verified by PCT #2 during an interview on 11/6/23 at 3:02 PM. On 11/7/23 at 1:05 PM, review of the policy provided by the dialysis clinic, entitled, “Cleaning and Disinfecting the Dialysis Station”, revealed, “...the nature of dialysis treatments with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious disease...The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis stations must be disinfected with 1:100 bleach...Externally disinfect the dialysis machine with 1:100 bleach solutions after each dialysis treatment...Use 1:100 bleach solution to clean surfaces with visible blood. After cleaning up all visible blood, use a new cloth with 1:100 bleach solution for a second cleaning of the surface. Make the surface glisteningly wet and let air dry unless otherwise specified by the manufacturer...”.”

“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: 28883 Based on observations, interview, and review of the facility’s policies, titled, “Central Venous Catheter Dressing Change” and “Initiation and Termination of Treatment Using a Central Venous Catheter”, one of two Registered Nurses observed performing a Central Venous Catheter dressing change and initiation of the patient’s dialysis treatment failed to ensure aseptic technique was observed during the procedures. RN #2 failed to perform hand hygiene after removing the soiled exit site dressing, failed to keep the tips of the saline syringes sterile, and failed to prevent possible cross contamination of respiratory secretions during access of the CVC. (RN #2) The findings included: Observations on 11/6/23 at 3:18 PM revealed Registered Nurse #2 in dialysis station 10 on dialysis machine 34 performing a patient’s dressing change to a Central Venous Catheter and accessing the CVC for dialysis treatment. RN #2 removed the old soiled exit site dressing and touched/handled the clean supplies before removing gloves and performing hand hygiene. RN #2 opened normal saline filled syringes and placed 2 of the syringes without caps covering the tips of the syringes onto the Chux where the tips of the syringes touched paper wrappings. As RN #2 was cleaning the catheter hubs with an alcohol pad and attaching syringes to the hubs, the patient pulled down his/her mask and removed the tempadot (single use thermometer) from his/her mouth and handed it to the nurse potentially cross contaminating the catheter hubs/supplies. During an interview on 11/6/23 at 4:05 PM, RN #2 verified the above observations. On 11/7/23 at 12:00 Noon, review of the facility policy provided by the dialysis clinic, entitled, “Central Venous Catheter Dressing Change”, revealed that after the old exit site dressing is removed, the nurse is to “...discard the dressing and remove gloves. Perform hand hygiene...”. Review of the policy “Initiation and Termination of Treatment Using a Central Venous Catheter”, revealed that “...A mask must be worn that covers the nose and mouth by staff, patient and care partner for all procedures that require accessing the catheter. Hand hygiene must be performed per policy: Hand Hygiene to prevent transmission of pathogenic microorganisms. Aseptic technique must be followed to prevent infection...”.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 28883 Based on observation, interview, and review of the Fresenius 2008T Hemodialysis Machine Operator’s Manual and the facility policy, titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate”, one of two Registered Nurses (RN) observed initiating a patient’s dialysis treatment failed to ensure the independent conductivity and pH of the dialysate had been checked in the ordered acid concentrate for the patient. (RN #2) The findings included: Observations on 11/6/23 at 3:30 PM revealed Patient Care Technician (PCT) #3 at dialysis machine 55 in dialysis station 9. Registered Nurse #2 and PCT #3 checked the independent conductivity and pH of the dialysate in a 2K (Potassium) 2.5 Ca (Calcium) acid concentrate. Registered Nurse #2 changed the dialysate from the 2K 2.5 Ca acid concentrate to a 2K 2.0 Ca acid concentrate and changed the settings on the dialysis machine to a 2K 2.0 Ca acid concentrate. At 3:49 PM, when nursing staff were getting ready to start the patient’s dialysis treatment, the surveyor asked RN #2 to verify the patient’s prescription orders and informed RN #2 of the concern related to the check of the conductivity and pH having been completed in the 2K 2.5 Ca acid concentrate and not the 2K 2.0 acid concentrate that had been ordered for the patient. RN #2 stated she/he had not heard of performing the check of conductivity and pH in the ordered concentrate. The patient’s treatment was started without checking the pH and conductivity of the ordered dialysate. On 11/7/23 at 2:00 PM, review of the Fresenius 2008T Hemodialysis Machine Operator’s Manual revealed under Recirculation and Final Set-Up Procedure that staff are to “Check the conductivity and pH of the dialysate....Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means before initiating each dialysis treatment. Review of the policy provided by the dialysis clinic entitled “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” revealed “...Trained teammates will test pH and conductivity of final dialysate using appropriate test strips and/or meters prior to each patient treatment...”.”

“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: 28883 Based on observation, interview, and review of the Fresenius 2008T Hemodialysis Machine Operator’s Manual and the Mar Cor Purification CWP 100 Service Manual, one of two Registered Nurses observed checking the patient’s orders before the start of the patient’s dialysis treatment failed to ensure the dialysis machine went through the alarm and pressure tests in the ordered acid concentrate. There was no documentation of the disinfection of the Continuous Water Purifier Reverse Osmosis for the week of 10/1/23. (RN #2) The findings included: Observations on 11/6/23 at 3:30 PM revealed Patient Care Technician #3 at dialysis machine 55 in dialysis station 9. At 3:37 PM, the dialysis machine was undergoing the machine alarm and pressure tests in a 2K 2.5 Ca acid concentrate. At 3:40 PM, the test was complete. Registered Nurse #2 changed the dialysate from the 2K 2.5 Ca acid concentrate to a 2K 2.0 Ca acid concentrate and changed the settings on the dialysis machine to a 2K 2.0 Ca acid concentrate. At 3:49 PM, when nursing staff were getting ready to start the patient’s treatment, the surveyor asked RN #2 to verify the patient’s orders and informed RN #2 of the concern related to the dialysis machine test having been completed in the 2K 2.5 Ca acid concentrate and not the 2K 2.0 acid concentrate that had been ordered for the patient. RN #2 stated she/he had not heard of performing the machine alarm and pressure tests in the ordered concentrate and had PCT #3 start the patient’s dialysis treatment. On 11/7/23, review of the Fresenius 2008T Hemodialysis Machine Operator’s Manual revealed that for manual machine setup, that staff are to insert the acid concentrate connector into an acid supply or jug containing sufficient acid concentrate for an entire treatment. Staff are to select the dialysis button for normal dialysis, and verify that the concentrate type displayed “...correctly matches the prescribed concentrate type, and that the acid/bicarbonate or acetate concentrates connected to the machine match the type selected. If an incorrect concentrate type is displayed, the correct concentrate must be entered.....When the machine is ready..it will begin mixing the concentrates...”.The blood lines will be set up and lines/dialyzer primed with saline. Under Testing the 2008T Hemodialysis Machine “Before beginning treatment, the 2008T hemodialysis machine should undergo Pressure and Alarm tests to ensure that it is functioning properly..To run the test sequence...The dialyzer lines must be connected to the shunt with the interlock door closed. The machine must be in an alarm-free condition by allowing sufficient time for the dialysate to reach proper conductivity and temperature. This takes about five minutes from the time the concentrate is confirmed on the “Dialysate” screen...Warning! It is essential that the 2008T hemodialysis machine’s balancing system is operating properly. The machine must successfully complete a Pressure test before each treatment, especially when using high-flux dialyzers..The Alarm test consists of tests that verify the integrity of the settable alarm limits of the system. Both the alarm and pressure tests should be conducted by the operator prior to each treatment...”. Review of the Daily Water logs for October 2023 revealed nursing staff had failed to document the weekly disinfection of the Reverse Osmosis machine with Minncare for October 1, 2023. The finding was verified by the clinic’s Biomedical Technician during an interview on 11/7/23 at 10:17 AM who stated staff are to document the weekly disinfection. Review on 11/8/23 at 10:49 AM of the Mar Cor Purification (MCP) CWP 100 Service Manual revealed under Chemical Disinfection, that “...As a guideline, MCP recommends a minimum weekly chemical disinfection to ensure consistent product water microbiological quality...”.”

“POC-MANAGE MINERAL METABOLISM CFR(s): 494.90(a)(3) Provide the necessary care to manage mineral metabolism and prevent or treat renal bone disease. This Standard is not met as evidenced by: 28883 Based on record reviews and interview, the dialysis clinic nursing staff failed to ensure Patient #5 who was one of three patients reviewed for mineral/bone metabolism received the dosage of Calcitriol as recommended by the dietitian. The findings included: The dialysis clinic admitted Patient #5 on 6/14/22 with diagnoses including End Stage Renal Disease. On 11/8/23 at 11:45 AM, review of the patient’s nutritional notes dated 10/18/23 revealed the patient’s total Calcium level was low on 10/11/23 at 8.3 mg/dl (milligrams/deciliter), below goal. The dietitian had documented that they would increase the patient’s dose of Calcitriol from 2.5 mcg (micrograms) three times weekly to 3 mcg. A review of physician orders revealed the medication dose had not changed and was still currently at 2.5 mcg. During an interview on 11/8/23 at 2:30 PM, the dietitian verified the above documentation and stated the Calcitriol dose should have been increased and this had been communicated to the nursing staff. After speaking with nursing, the dietitian came back and stated that the nursing staff had “missed” the change in dose.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 28883 Based on record reviews, interview, and review of the facility policy, titled, “Patient Assessment and Monitoring”, the dialysis clinic’s nursing staff failed to ensure vital signs had been documented timely during patient treatment for 5 of 10 patients reviewed. (Patient #1, #3, #4, #5, and #7) The findings included: On 11/8/23 at 12:09 PM, review of the patient’s dialysis treatment sheets revealed the following vital signs had not been documented timely indicating inappropriate monitoring of patients: Patient #1- Vital signs were documented on 11/6/23 at 6:22 AM and again at 7:28 AM; 11/1/23 at 8:37 AM and again at 9:39 AM; on 10/27/23 at 9:06 AM and again at 10:02 AM; and on 10/18/23 at 6:37 AM and again at 7:30 AM, and at 9:01 AM and again at 10:07 AM. Patient #3 - Vital signs were documented on 10/18/23 at 2:11 PM and again at 3:12 PM. Patient #4- Vital signs were documented on 10/25/23 at 7:30 AM and again at 8:29 AM. Patient #5- Vital signs were documented on 11/1/23 at 7:58 AM and again at 8:58 AM. Patient #7- Vital signs were documented on 10/26/23 at 10:24 AM and again at 11:29 AM. The findings were verified by the Clinic Manager during an interview on 11/8/23 at 3:15 PM. On 11/8/23,review of the policy provided by the dialysis clinic, entitled, “Patient Assessment and Monitoring” revealed that during treatment, staff would obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations.”