Fmc University Dialysis Center (Bma of Shrewsbury)

“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: 31240 Based observation, interview and policy review, the facility failed to ensure that 1 staff member (Patient Care Technician [PCT] #1) implemented adequate infection control measures related to glove use and hand hygiene, while caring for patients and touching patient equipment. Findings include: Review of the facility’s policy entitled, Hand Hygiene, dated 11/6/23, included the following: *Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap. *Hands shall be washed specifically with soap and water, or alcohol-based hand rubs, including: -Before and after direct contact with patients. -Immediately after removing gloves. -After contact with body fluids or excretion, mucous membranes, non-intact skin, wound dressings if hands are not visibly soiled. -After contact with inanimate objects near the patient. -After contact with other objects within the patient station or treatment space. *Procedure for decontamination of hands with alcohol-based hand rubs, includes the following: -If gloves are worn, remove and discard in appropriate waste container, expose the skin for decontamination. -Apply alcohol-based hand rub to the palm of one hand. -Rub hands together covering all surfaces of the hands and fingers, until hands are dry. On 3/18/25 at 9:05 A.M., the surveyor observed PCT #1 preparing to discontinue treatment for a patient in station 16. After using the computer, he removed his gloves and without performing hand hygiene, donned a clean pair of gloves, prior to caring for the patient. On 3/18/25 at 9:15 A.M., the surveyor observed PCT #1 remove his gloves and without performing hand hygiene, donned a clean pair of gloves, prior to caring for patient in station 16. During an interview on 3/18/25 at 9:22 A.M., PCT #1 said that after removing dirty gloves, he is supposed to use alcohol hand gel, then apply new gloves. He said he may of missed doing that. He also said that he should have changed his gloves when moving from sterile to non-sterile items during the discontinuation process. During an interview on 3/19/25 at 8:45 A.M., Registered Nurse #1 said that staff are required to use alcohol hand gel between gloves changes. She said glove changes and hand hygiene are required when staff move between clean and dirty items while caring for a patient.”

“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: 31240 Based on observation, interview and policy review, the facility failed to ensure 1 staff member (Patient Care Technician [PCT] #1) wore personal protective equipment (PPE) appropriately when there was a risk of blood splatter during termination of dialysis treatment for 2 of 3 applicable patients observed (#5 and #9) with an arteriovenous fistula (AVF-a surgical connection between an artery and vein, creating a pathway for blood flow essential for hemodialysis), out of a total sample of 9 patients. Findings include: Review of the facility’s policy entitled PPE, dated 11/6/23, included the following: *PPE including a full-faced shield or mask and protective eyewear with full side shield, fluid-resistant gowns, and gloves, must be worn to protect employees from blood or other potentially infectious materials (OPIM). *PPE is used to protect employees who are occupationally exposed to blood or OPIM when performing procedures in which spurting or splattering of blood might occur (example-during termination of dialysis). *A fluid resistant gown may be reused by the original owner for as long as it is clean and intact. *PPE fluid resistant gowns must be changed whenever visibly soiled or in disrepair. On 3/18/25 at 9:05 A.M., the surveyor observed PCT #1 terminate treatment for Patient #5. During the procedure, blood splattered onto the left sleeve and side of PCT #1’s gown. On 3/18/25 at 10:05 A.M., the surveyor observed PCT #1 terminate treatment for Patient #9. PCT #1 was still wearing the same gown that had blood splatters on it. During an interview on 3/19/25 at 8:45 A.M., the Director of Operations and Registered Nurse (RN) #1 said that staff should change their gown if it becomes soiled during patient care. RN #1 said PCT #1 should have changed his gown when it became dirty with blood during the termination process for Patient #5, before moving to the termination process for Patient #9. .”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 44223 Based on observation, staff interview, and policy review, the facility failed to provide evidence that the isolation room had dedicated equipment for use only for Hepatitis B positive patients. Findings Include: Review of the facility policy, titled Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+), published 11/6/23, indicated the following: *Caring for HBsAg positive patients requires adherence to strict guidelines. The hepatitis B virus is highly infectious because the concentration of virus particles in the blood is very high and the hepatitis B virus can live outside the body on surfaces for at least 7 days. Outbreaks of hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not been vaccinated for hepatitis B. *All supplies used in the isolation room/area such as clamps, blood pressure cuffs,testing reagents, etc., should be labeled “isolation” and not routinely removed. On 3/18/25 at 10:00 A.M., during observation of the isolation room, the surveyor observed the following items not labeled for isolation room use only: stethoscope, dialysis chair, oxygen concentrator, biohazard bucket, hemodialysis machine and the spectra lab machine. During an interview on 3/18/25 at 2:00 P.M., the Director of Operations said that they thought that if there were no hepatitis B patients being treated at the facility, then the items in the isolation room did not need to be labeled because any patient could utilize the isolation room for treatment.”

“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: 31240 Based on record review and interview, the facility failed to ensure the dialysis treatment order was delivered as prescribed, relative to Blood Flow Rate [BFR]-speed measured in millimeter per minute [ml/min] in which the patient’s blood is pushed through the dialysate and back into the body) and Dialysate Flow Rate (DFR-the measurement of how fast the dialysis solution flows in ml/min to draw toxins from the patient’s blood) for 3 of 7 applicable patient’s (#2, #4, and #7) records reviewed, out of a total sample of 9 patients. Finding include: 1. For Patient #2, the facility failed to ensure the dialysis prescription was delivered as prescribed relative to the BFR. Patient #2 was admitted to the facility in December 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis 3 times a week. Review of a physician’s order, dated 2/24/25, indicated the BFR was to be delivered at a rate of 450 ml/min. Review of 9 Hemodialysis Flowsheets, dated 2/26/25 through 3/17/25, indicated the BFR had not been delivered as prescribed for 3 of 9 hemodialysis treatments as follows: *2/26/25 - The BFR was delivered at a rate between 350-400 ml/min during part of the treatment, not 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/5/25 - The BFR was delivered at a rate of 350 ml/min, not 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/10/25 - The BFR was delivered at a rate of 400 ml/min during part of the treatment, not 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. 2. For Patient #4 the facility failed to ensure the dialysis prescription was delivered as prescribed relative to the BFR and DFR. Patient #4 was admitted to the facility in February 2023 with a diagnosis of ESRD, requiring hemodialysis treatments 3 times a week. Review of a physician’s order, dated 1/23/25, indicated the BFR was to be delivered at a rate of 450 ml/min and the DFR was to be delivered at Autoflow (AF) rate (1.5 times the BFR rate: 675 ml/min). Review of 9 Hemodialysis Flowsheets, dated 1/28/25 through 3/8/25, indicated the BFR and/or DFR had not been delivered as prescribed for 4 of 9 hemodialysis treatments as follows: *2/4/25 - The DFR was delivered at 600 ml/min and 800 ml/min during part of the treatment, not 675 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *2/26/25 - The DFR was delivered at 500 ml/min, not 675 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/4/25 -The BFR was delivered at 300 ml/min and the DFR was delivered at 500 ml/min during part of the treatment, and there was no documentation to indicate why the physician’s order was not followed. *3/8/25 - The BFR was delivered at 330 ml/min and the DFR was delivered at 600 ml/min during part of the treatment, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 3/19/25 at 10:30 A.M., Registered Nurse (RN) #5 said that if the BFR and/or DFR are not delivered as ordered, then staff should document the reason the prescription ordered by the physician was not followed. During an interview on 3/19/25 at 1:00 P.M., after reviewing the clinical records of Patient #2 and #4, RN #5 said there was no documentation by staff indicating why the BFR and/or DFR were not delivered as ordered during the 4 treatments noted above. 27189 3. For Patient #7, the facility failed to ensure the dialysis prescription was delivered as prescribed, relative to the BFR and/or DFR Patient #7 was admitted to the facility in May 2022 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis 3 times a week. Review of the physician’s order, dated 1/31/25, indicated the BFR was to be delivered at a rate of 350 ml/min, and the DFR was to be run at a rate of 600 ml/min. Review of 9 Hemodialysis Flowsheets, dated 2/26/25 through 3/17/25, indicated the BFR and/or the DFR had not been delivered as prescribed for 5 of 9 hemodialysis treatments as follows: *2/28/25 - The DFR was delivered at a rate of 800 ml/min , not 600 ml/min as ordered, with no documentation to indicate why the physician’s order was not followed. *3/5/25 - The BFR was delivered at a rate of 275 ml/min, not 350 ml/min as ordered, with no documentation to indicate why the physician’s order was not followed. *3/7/25 - The DFR was delivered at a rate of 800 ml/min, not 600 ml/min as ordered, with no documentation to indicate why the physician’s order was not followed. *3/10/25 - The DFR was delivered at a rate of 800 ml/min, not 600 ml/min as ordered, with no documentation to indicate why the physician’s order was not followed. *3/12/25 - The DFR was delivered at a rate of 800 ml/min, not 600 ml/min as ordered, with no documentation to indicate why the physician’s order was not followed. During an interview on 3/19/25 at 9:15 A.M., the Director of Operations and RN #5 said staff must follow the physician’s order for the BFR and/or DFR and said that if the staff cannot deliver the ordered BFR and/or DFR rate, they should document the justification and/or physician notification.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 44223 Based on record review, staff interview, and policy review, the facility failed to provide the necessary monitoring and social work interventions to assist patients in achieving and sustaining an appropriate psychosocial status, as measured by a standardized mental and physical assessment tool chosen by the social worker (SW), (Kidney Disease Quality of Life Survey-[KDQOL-36]) at regularly interval, or more frequently on as needed basis for 2 of 7 (#1,#5) medical records reviewed out of a total sample of 9 patients. Findings Include: Review of the facility policy, titled Measuring Patient Physical and Mental Function, published 1/2/25, indicated the following: *The KDQOL-36 is administered to patients new to dialysis between the 3rd and 4th month of starting dialysis as part of the patient’s 90 day assessment and plan of care. *At a minimum, the KDQOL-36 will be administered annually with each patient as part of the annual assessment and plan of care. The KDQOL-36 may be administered at more frequent intervals as determined by the Social Worker or IDT to assist with patient’s plan of care *Patients may not be eligible or able to complete the KDQOL-36 for the following reasons: -Cognitive or psychiatric barriers that affect the patient’s ability to participate. -The patient speaks or reads a language other than English or Spanish or for which there is no validated translation available. -The patient is under 18. *Patients have the right to refuse to complete the KDQOL-36. However, every effort should be made to ensure that proper education has been provided about how completion benefits the patient and team in identifying the areas of concern to be addressed as part of the patient’s plan of care. *When a survey is not completed, the reason for this must be documented in the patient’s medical record in the form of a progress note or Exclusion report printed from the KDQOL-36 application. This note should include the date the survey was presented to the patient and/or parent/guardian and the reason it was not completed. 1. Patient #1 was admitted to the facility in July 2024 with a diagnosis of End Stage Renal Disease (ESRD) requiring hemodialysis three times a week. Review of the 90 day comprehensive assessment, dated 11/20/24 and the corresponding care plan, dated 12/19/24, indicated the Social Worker documented the KDQOL-36 status was not completed, patient refused. The documentation indicated the KDQOL-36 would be completed at a later date. Further review of the medical record did not indicate any further documented evidence in the Social Worker’s progress notes that the patient was reapproached to complete the KDQOL-36 or that education was provided on the benefits of completing the KDQOL-36 to help the interdisciplinary team identify areas of concern. During an interview on 3/19/25 at 9:15 A.M., the Social Worker said that he does at times try to attempt to talk to patients about completing the KDQOL-36 but that he does not document in the medical record when he does this. 2. Patient #5 was admitted to the facility in April 2019 with a diagnosis of ESRD requiring hemodialysis three times a week. Review of the medial record indicated a KDQOL-36 Exclusion/Refusal Report, dated 9/12/24. The form indicated the reason the form was not completed was due to a language barrier. The form was not dated or signed by the Social Worker. Further review of the medical record indicated that all assessments were completed by the interdisciplinary team and that there was no documented evidence to indicate that there was a language barrier. During an interview on 3/19/25 at 9:15 A.M., the Social Worker said he did not complete a KDQOL-36 for this patient. During an interview on 3/19/25 at 2:10 P.M., the Director of Operations said they do have a language hotline that they can utilize and other forms of communication to use for patients that speak a different language. She said that there should of been other attempts to complete the KDQOL-36 by using these other forms of communication.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 27189 Based on observation, record review, policy review and staff interview, the Medical Director failed to ensure that staff adhered to the heparin administration policy and administered and/or documented that they waited 3-5 minutes after administration of heparin (blood thinning medication) to initiate dialysis treatment for 3 patients (#6 , #7 and #8) in a total sample of 9 patients. Findings Include: Review of the facility’s policy titled, Heparin Bolus Administration, published 11/1/21, indicated the following: * Allow heparin to circulate within the bloodstream for a minimum of 3-5 minutes before initiating treatment to prevent blood from clotting in the dialysis circuit. 1. For Patient #8, the Medical Director failed to ensure that the staff administered a heparin bolus, 4000 units, intravenously (IV) prior to the initiation of dialysis according to the physician’s order. During an observation on 3/18/25 at 10:28 A.M., Patient Care Technician (PCT) #3 completed an initiation of dialysis with a Central Venous Catheter (CVC) for Patient #8. PCT #3 did not administer a heparin bolus prior to the initiation of treatment. On 3/19/25 at 7:40 A.M., review of the Treatment Flowsheet for Patient #8, dated 3/18/25, indicated a current physician’s order to receive a bolus of Heparin 4000 units IVP every treatment. During an interview on 3/19/25 at 8:30 A.M., PCT #3 said that he had not administered the bolus of heparin prior to initiation of dialysis and should have. He said he realized he had forgotten to obtain the heparin for administration, but that once the surveyor was done with the observation, he told RN #5, and then administered the heparin bolus. PCT #3 said that the bolus of heparin should have been administered prior to the initiation of dialysis. 2. For Patient #7, the Medical Director failed to ensure that staff adhered to the heparin administration policy and wait 3-5 minutes after administration to initiate dialysis treatment. Review of the clinical record indicated that Patient #7 had a physician’s order to administer a heparin bolus of 4000 units IV push, every dialysis treatment. Review of 9 treatment sheets, dated 2/26/25 through 3/17/25, indicated that for 3 of 9 treatments, staff failed to wait 3-5 minutes after the administration of the heparin to initiate treatment including the following: * On 3/10/25 treatment started at 10:56 A.M., heparin was documented as administered at 10:56 A.M., 0 minutes prior to the initiation of treatment, not the 3-5 minutes prior to initiation, per the facility policy. * On 3/12/25 treatment started at 11:40 A.M., heparin was documented as administered at 11:40 A.M., 0 minutes prior to the initiation of treatment, not the 3-5 minutes prior to the initiation of treatment, per the facility policy. *On 3/17/25 treatment started at 11:00 A.M., heparin documented as administered at 11:00 A.M., 0 minutes prior to the initiation of treatment, not the 3-5 minutes prior to initiation of treatment, per the facility policy. During an interview on 3/19/25 at 9:15 A.M., the Director of Operations and Registered Nurse (RN) #5 said that staff did not follow the heparin administration policy. 31240 3. For Patient #6, the Medical Director failed to ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration to initiate treatment. Review of the clinical record indicated that Patient #6 had a physician’s order to administer a heparin bolus of 3000 units IV push, every dialysis treatment. Review of 9 treatment sheets, dated 2/26/25 through 3/17/25, indicated for 3 of 9 treatments, staff failed to wait 3-5 minutes after the administration of the heparin to initiate treatment including the following: *On 3/3/25 treatment started at 2:02 P.M., heparin was documented as administered at 2:03 P.M., 1 minute after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 3/10/25 treatment started at 2:25 P.M., heparin was documented as administered at 2:38 P.M., 13 minutes after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 3/12/25 treatment started at 2:05 P.M., heparin was documented as administered at 2:06 P.M., 1 minute after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. During an interview on 3/19/25 at 1:00 P.M., RN #5 said staff did not wait the 3-5 minutes to initiate treatment, after administering the heparin bolus, for the 3 treatment sessions noted above. She said the staff did not follow the facility policy as required.”