Fmc - Topeka East

“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: 40633 Based on review of the Emergency Preparedness Plan (EPP), document review, and an interview, the aboved named End Stage Renal Disease (ESRD) facility failed to develop and maintain an emergency preparedness plan that addresses the patient/client population. Findings Include: Review of the facility’s Emergency Preparedness Program (EPP), last reviewed by the facility in 2025, showed that the plan did not address the patient or client population, including persons at risk, the types of services the facility can provide during an emergency, and continuity of operations with delegations of authority and succession plans. During an interview on 03/19/25, the Administrator confirmed that there were no policies or procedures in place to ensure that the emergency preparedness plan addressed the patient or client population, including services provided in emergencies and continuity of operations.”

“Roles Under a Waiver Declared by Secretary CFR(s): §403.748(b)(8), §416.54(b)(6), §418.113(b)(6)(C)(iv), §441.184(b)(8), §460.84(b)(9), §482.15(b)(8), §483.73(b)(8), §483.475(b)(8), §485.542(b)(7), §485.625(b)(8), §485.920(b)(7), §494.62(b)(7). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (8) [(6), (6)(C)(iv), (7), or (9)] The role of the [facility] under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials. *[For RNHCIs at §403.748(b):] Policies and procedures. (8) The role of the RNHCI under a waiver declared by the Secretary, in accordance with section 1135 of Act, in the provision of care at an alternative care site identified by emergency management officials. This Standard is not met as evidenced by: 40633 Based on review of Emergency Preparedness Plan (EPP), document review, and interview, the above named End Stage Renal Disease (ESRD) facility failed to develop and implement policies and procedures for the role of the facility under a waiver declared by the Secretary. The deficient practice included a lack of documented procedures for the provision of care and treatment at an alternate care site identified by emergency management officials during a declared waiver. Findings Include: Review of the facility’s Emergency Preparedness Program (EPP), last reviewed by the facility in 2025, failed to include policies or procedures for the role of the facility under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care at an alternate care site identified by emergency management officials. During an interview on 03/19/25, the Administrator confirmed there were no policies or procedures for the role of the facility under a waiver declared by the Secretary for the provision of care at an alternative care site.”

“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: 50529 Based on observation, policy review, and interview, the facility failed to ensure patients washed their hands or performed hand hygiene after holding their dialysis (a medical treatment that removes waste products and excess fluid from the blood when the kidneys are unable to do so) access site (a surgically created entry point into the bloodstream) after treatment. This deficient practice provided a mode of contamination with the potential spread of infectious pathogens (organisms that may cause disease or infection) which could negatively impact the health and well-being of the 36 patients that received dialysis treatments at the facility. Findings Include: Review of a policy titled, “Hand Hygiene,” dated 11/06/23, showed, “ ...Patients should perform hand hygiene if able, prior to and after each dialysis treatment ... Gloves must be provided to patients when performing procedures which risk exposure to blood or body fluids, such as when self-cannulating or holding access sites post treatment to achieve hemostasis. To help ensure the prevention of cross contamination to their family member or other patients, hand hygiene must be performed...” During an observation at station #9 on 03/19/25 from 10:47 AM to 11:12 AM, Staff F, Clinical Certified Hemodialysis Technician (CCHT), failed to offer/provided hand sanitizer to patient or encourage hand washing after holding access sites. Patient was still wearing a glove when buttons were touched at the scale to weigh. The patient left the treatment floor with the glove still on. During an observation at station #2 on 03/19/25 at 11:19 AM, Staff D, CCHT, escorted patient to the scale to weigh after holding access sites. Staff D assisted the patient with the removal of the glove, but did not suggest hand washing or offer hand sanitizer before the patient left the treatment floor. During an observation at station #3 on 03/24/25 at 11:07 AM, Staff C, Registered Nurse (RN), escorted patient to the scale to weigh after access sites were held. The patient was not offered/reminded of hand washing or hand sanitizer before leaving the treatment floor. During an interview on 03/19/25 at 5:31 PM, Staff A, Clinical Manager and Staff B, Director of Operations, confirmed that the facility’s policy is to be followed for hand hygiene when providing care and that failure to do so could lead to infection and/or other negative outcomes for patients, staff, and visitors.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 50529 Based on observation, policy review, and interview, the facility failed to ensure staff wore personal protective equipment (PPE) (gowns) correctly on 3 of 3 observation days. Failure to wear PPE correctly provided a mode of cross contamination with the potential spread of infectious pathogens (organisms that may cause disease or infection) which could negatively impact the health and well-being of the 36 patients that received dialysis treatments at the facility. Findings Include: Review of a policy titled, “Personal Protective Equipment,” dated 11/06/23, showed , “ ...Personal protective equipment including ... fluid-resistant gowns ... must be worn to protect employees from blood or other potentially infectious materials ...” During observation on 03/19/25 at 3:55 PM, Staff C, Registered Nurse (RN), went to station #13 and station #1 without wearing a fluid-resistant gown. During observation on 03/19/25 at 4:42 PM, Staff H, Administrative Assistant (AA), was on the treatment floor visiting with patients chairside at stations #2, #6, and #13 without wearing a fluid-resistant gown. During an interview on 03/19/25 at 5:31 PM, Staff A, Clinical Manager and Staff B, Director of Operations, confirmed that the facility policy for PPE is to be followed by all staff and stated that failure to do so could possibly lead to infection and/or other negative outcomes for patients.”

“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: 50529 Based on observation, policy review, and interview, the facility failed to ensure staff followed aseptic technique when preparing intravenous (IV) medication during 1 of 2 medication preparation observations. This deficient practice placed any patient who received IV medication at risk for exposure to infectious pathogens (microorganisms that could potentially cause disease in humans and other living organisms) and could negatively impact the health and well-being of the 36 patients who received treatment at the facility. Findings Include: Review of a policy titled, “Medication Preparation and Administration,” dated 02/06/2023, showed, “ ... Aseptic technique will be used to prepare and administer IV [intravenous] medication ...Cleanse the diaphragm [needle entry point] of a vial with alcohol prior to accessing the vial If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol. Allow to dry before inserting a device into the vial...” During observation on 03/19/25 at 10:53 AM, Staff E, Certified Clinical Hemodialysis Technician (CCHT), prepared a 1 mL (milliliter) syringe with 1:100-unit heparin (a medication used as an anticoagulant) without cleansing the diaphragm of the vial with an alcohol wipe before inserting the needle. During an interview on 03/19/25 at 11:00 AM, Staff E, CCHT, stated that she didn’t realize that she forgot to wipe the diaphragm of the vial before inserting needle. Staff E confirmed this observation as a deficient practice and stated that failure to use aseptic technique could pose a possible threat of infection. During an interview on 03/19/25 at 5:31 PM, Staff A, Clinical Manager, stated that Staff E’s failure to follow aseptic technique when preparing IV medications could possibly lead to infection and/or other negative outcomes for patients.”

“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: 50529 Based on observation, policy review, and interview, the facility failed to ensure staff wore a face mask that covered both the nose and mouth during treatment initiation for a patient with a central venous catheter (CVC) [tube inserted into a central vein to allow access to the bloodstream] during 3 of 3 observations . This deficient practice increases the risk of bloodstream infections that may negatively impact the health and well-being of any patient with a CVC that receives dialysis [a medical treatment that removes waste products and excess fluid from the blood when the kidneys are unable to do so] treatment at this facility. Findings Include: Review of a policy titled, “Initiation and Termination of Treatment Using a Central Venous Catheter (CVC),” dated 11/04/24, showed, “ ...The catheter exit site and hubs are the two primary sources for microorganism access which can result in a blood stream infection (BSI). Catheter related infections are one of the leading causes of hospitalization and death. Strict infection control practices and adherence to the procedure is essential to prevent serious complications ...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...” During an observation at station #2 on 03/19/25 at 3:29 PM, Staff C, Registered Nurse (RN), failed to ensure her face mask covered her nose during treatment initiation of a patient with a CVC. During an interview on 03/19/25 at 5:31 PM, Staff A, Clinical Manager and Staff B, Director of Operations, stated that facility policy for personal protective equipment (PPE) is to be followed by all staff and stated that failure to do so could possibly lead to infection and/or other negative outcomes for patients. During an interview on 03/20/25 at 1:12 PM, Staff A, Clinical Manager stated that staff must wear a face mask in addition to other required PPE when conducting any CVC procedures. Staff A stated that failure to wear a face mask would not only be a deficient practice but would also pose a risk for infection or worse outcomes for patients with CVCs.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 50529 Based on policy review, record review, and interview, the facility failed to monitor patient vital signs for 4 of 5 (Patient 1, 2, 4, and 5) sampled patients during dialysis (a medical treatment that removes waste products and excess fluid from the blood when the kidneys are unable to do so) treatment. Failure to monitor patient vital signs increased the risk for changes in patient condition going unrecognized and/or unaddressed and has the potential to negatively impact the health and well-being of the 36 patients who received dialysis treatments at the facility. Findings Include: Review of a policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, showed, “ ...During Treatment ... Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes ... Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes...” Patient 1 Patient 1’s treatment sheet, dated 03/19/25, showed no vital signs nor machine settings were completed for 53 minutes from 3:59 PM to 4:51 PM. Documentation failed to show rationale why patient monitoring data was not completed. Patient 2 Patient 2’s treatment sheet, dated 03/10/25, showed a blood pressure and pulse were not completed for 62 minutes from 10:36 AM to 11:38 AM. Documentation failed to show rationale why patient monitoring data was not completed. Patient 2’s treatment sheet, dated 03/07/25, showed a blood pressure and pulse were not documented for 58 minutes from 10:30 AM to 11:28 AM. Documentation failed to show rationale why patient monitoring data was not completed. Patient 4 Patient 4’s treatment sheet, dated 03/12/25, showed a blood pressure and pulse were not documented for 77 minutes from 2:15 PM to 3:32 PM. Documentation failed to show rationale why patient monitoring data was not completed. Patient 5 Patient 5’s treatment sheet, dated 03/12/25, showed no blood pressure and pulse for 56 minutes from 10:56 AM to 11:57 AM. Documentation failed to show rationale why patient monitoring data collection was not completed. Patient 5’s treatment sheet, dated 03/14/25, showed no blood pressure and pulse for 64 minutes from 12:31 PM to 1:35 PM. Documentation failed to show rationale why patient monitoring data collection was not completed. During an interview on 03/20/25 at 1:12 PM, Staff A, Clinical Manager, stated that staff are expected to monitor patients the entire time on treatment and to input vital signs, machine pressures, and an observation note, if needed, every 30 minutes. Staff A stated that failure to follow this guidance could lead to negative outcomes for the patient due to the possibility of missing and/or not addressing a change in patient condition that could be potentially harmful, or even fatal. During an interview on 03/24/25 at 10:54 AM, Staff D, Certified Clinical Hemodialysis Technician (CCHT) stated that staff were expected to monitor patients all treatment and enter vitals, machine parameters, and a note of observation every 30 minutes unless there are any changes or issues requiring an increased occurrence.”

“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: 50529 Based on record review and policy review the facility failed to follow the individualized dialysis (a medical treatment that removes waste products and excess fluid from the blood when the kidneys are unable to do so) prescription as prescribed by the medical provider for 5 of 5 (Patient 1, 2, 3, 4, and 5) sampled patients. Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the dialysis treatments and the health and well-being of the 36 in-center patients who received dialysis treatments at the facility. Findings Include: Review of a policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, showed, “ ...Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered ...” Review of a policy titled, “Physician Order Documentation,” dated 07/03/23, showed, “It is the nurses’ responsibility to ensure that all treatments, medications, labs or any care provided to the patient have an accurately documented physician order ...Nurse practice acts require nurses to carry out treatment care, medication administration, lab tests, procedures, and other treatments, based on physician orders ...” Patient 1 Patient 1’s treatment sheet, dated 03/10/25, showed a prescribed dialysate flow rate (DFR) of 800 milliliters per minute (mL/min) and prescribed blood flow rate (BFR) of 350 milliliters per minute (mL/min). The BFR was documented as 450 mL/min and 500 mL/min during the entire treatment. Documentation failed to show rationale why the prescribed BFR was not attained. Patient 1’s treatment sheet, dated 03/12/25, showed a prescribed DFR of 800 mL/min and prescribed BFR of 350 mL/min. Documentation failed to show BFR or other prescribed machine parameter entries from 2:30 PM to 4:00 PM. Documentation failed to show rationale why the prescribed DFR and BFR were not attained. Patient 1’s treatment sheet, dated 03/19/25, showed a prescribed DFR of 800 mL/min and prescribed BFR of 350 mL/min. The BFR was documented as 450 mL/min from 2:16 PM to 2:36 PM. The BFR was documented as 400mL/min from 3:38 PM to 5:06 PM. Documentation failed to show rationale why the prescribed BFR was not attained throughout treatment. Patient 2 Patient 2’s treatment sheet, dated 03/07/25, showed a prescribed BFR of 500 mL/min. The BFR was documented as 400 mL/min for 52 minutes from 1:01 PM to 1:53 PM. Documentation failed to show rationale why the prescribed BFR was not maintained. Patient 2’s treatment sheet, dated 03/14/25, showed a prescribed BFR of 500 mL/min. The BFR was documented as 450 mL/min during the entire treatment. Documentation failed to show rationale why the prescribed BFR was not attained. Patient 3 Patient 3’s treatment sheet, dated 12/11/24, showed a prescribed DFR of 800 mL/min and a prescribed BFR of 500mL/min. The BFR was documented as 350 mL/min the entire treatment. Documentation failed to show rationale why the prescribed BFR was not attained. Patient 3’s treatment sheet, dated 12/16/24, showed a prescribed DFR of 800 mL/min and a prescribed BFR of 500mL/min. The BFR was documented as 350 mL/min the entire treatment. Documentation failed to show rationale why the prescribed BFR was not attained. Patient 3’s treatment sheet, dated 12/18/24, showed a prescribed DFR of 800 mL/min and a prescribed BFR of 500mL/min. The BFR was documented as 400 mL/min for 27 minutes from 12:33 PM to 1:06 PM. The BFR was documented as 300 mL/min at 2:04 PM and 350 mL/min at 2:36 PM. Documentation failed to show rationale why the prescribed BFR was not maintained at prescribed parameters. Patient 3’s treatment sheet, dated 12/24/24, showed a prescribed DFR of 800 mL/min and a prescribed BFR of 500 mL/min. The BFR was documented as 350 mL/min the entire treatment. Documentation failed to show rationale why the prescribed BFR was not attained. Patient 4 Patient 4’s treatment sheet, dated 03/05/25, showed a prescribed DFR of 500 mL/min and a prescribed BFR of 350 mL/min. The DFR and BFR were not documented from 2:30 PM to 4:00 PM. Documentation failed to show rationale why the prescribed DFR and BFR were not attained. Patient 4’s treatment sheet, dated 03/12/25, showed a prescribed DFR of 800 mL/min and a prescribed BFR of 450mL/min. The BFR was documented as 400 mL/min during the entire treatment. Documentation failed to show rationale why the prescribed BFR was not attained. Patient 5 Patient 5’s treatment sheet, dated 03/07/25, showed a prescribed DFR of 500 mL/min, BFR of 300 mL/min. The BFR was documented as 450 mL/min and 500 mL/min during the entire treatment. Documentation failed to show rationale why the prescribed BFR was not attained.”