Fmc - Highland

“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: 39802 Based on document review, observation, and interview, it was determined that for 1 of 3 staff (E#3) observed providing patient care on 02/04/2025, the Facility failed to ensure that staff changed gloves and performed hand hygiene when moving from patient-to-patient/station-to-station. This had the potential to affect all in-center hemodialysis patients on census. Findings include: 1. The Facility’s policy titled, “Hand Hygiene” (dated 11/06/2023), was reviewed and required, “...Decontaminate 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 inanimate objects near the patient...” 2. During a tour of the dialysis treatment area on 02/04/2025, the following was observed: - At approximately 9:14 AM, Registered Nurse (E#3) touched the machine at station #11. E#3 then changed gloves and went to grab new supplies from the clean storage area at the nurse’s station without performing hand hygiene. E#3 then returned to station #11, adjusted E#3’s faceshield, then change gloves again without performing hand hygiene. - At approximately 9:30 AM, E#3 changed gloves after leaving station #7 and went to station #10 without performing hand hygiene. Then at 9:32 AM, E#3 changed gloves again going from station #10 to station #11 without performing hand hygiene. Then at 9:33 AM, E#3 changed gloves again going from station #11 to station #6 without performing hand hygiene. - At approximately 9:35 AM, E#3 was providing care at to the patient at station #8 and removed gloves to get supplies from the nurse’s station. E#3 did not performing hand hygiene after removing gloves. - At approximately 10:17 AM, E#3 was observed touching the machine at station #6 then station #7 and then station #8 with the same pair of gloves. 3. An interview was conducted with E#3 on 02/04/2025, at approximately 12:30 PM. E#3 stated that hand hygiene should be performed when removing gloves and gloves should be changed when going from patient to patient.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 51457 Based on document review, observation, and interview, it was determined that for 2 of 2 staff (E#2 and E#3) performing chlorine testing, the Facility failed to ensure that unexpired strips were used to conduct chlorine testing. This had the potential to affect all in-center hemodialysis patients on census. Findings include: 1. The Facility’s policy titled, “Total Chlorine Testing using RPC Ultra Low Total Chlorine Test Strips” (dated 04/2021) was reviewed and included, “...The following supplies will be needed for this procedure: Unexpired RPC Ultra Low Total Chlorine Test Strip ...” 2. The chlorine test strip’s manufacturer instruction were reviewed and required: “Do not use a test strip after the expiration date.” 3. On 02/04/2025 at approximately 11:55 AM, during an observational tour of the water treatment room, a Patient Care Technician/PCT (E#2) was performing a chlorine test using expired chlorine strips with an expiration date of 11/30/2024. The nurse (E#3) was also present to observe the test. There were an additional 96 chlorine test strips that expired on 11/30/2024 that were available for use. The strips were in the bag dated 02/01/2025. 4. On 02/04/2025, at approximately 12:15 PM, the PCT (E #2) was interviewed. E#2 stated that the strip’s expiration should have been checked before testing. E#2 stated they should not have used expired strips to test for chlorine and E#2 stated that the purpose of the test is to ensure the water is safe for dialysis treatment.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 1 of 1 water purification system (RO), the Facility failed to ensure that the system was disinfected based on manufacturer’s recommendations. Findings include: 1. The RO manufacturer’s instructions for use (undated) was reviewed and required, “...MINNCARE Liquid Disinfectant is recommended for sanitizing reverse osmosis membranes and their associated distribution systems... Prepare a 1% solution... by adding the MINNCARE Liquid Disinfection solution to permeate water... Recirculate the 1% MINNCARE Liquid Disinfectant until the entire system is filled. Allow the elements to soak in the 1% MINNCARE Liquid Disinfection solution for a minimum of 36 minutes at 20 [degrees Celsius]... Rinse the RO system and check for residuals by following the directions on the MINNCARE Residual Test Strips label...” 2. The MINNCARE HD Test Strips information sheet was reviewed and included, “...MINNCARE HD 1% Test Strips verify adequate concentration of a 1% Minncare solution during sanitization of your hemodialysis water purification system. These convenient dip-and-read strips can be used at any test port in your system to provide an accurate pass/fail measurement of Minncare HD Disinfectant...” 3. The Facility’s Monthly RO Disinfection records from 08/18/2024-01/16/2025 were reviewed and indicated that a positive test for Minncare disinfectant should be >= (greater than or equal to) 400 ppm [parts per million] [equivalent to 1% MINNCARE HD] 4. An interview was conducted with the Biomedical Technician (E#4) on 02/04/2025, at approximately 3:00 PM. E#4 brought a bottle of Minncare HD Residual Test Strips when asked what strips are used when performing Minncare disinfection of the RO system. E#4 stated that these strips were used to test for both positive and negative presence of Minncare in the system. E#4 stated that the strip should be 0 to indicate absence of disinfectant when testing for residual and black if testing for positive presence. E#4 stated that positive presence for Minncare should at least 500 ppm.”

“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: 36774 A. Based on document review and interview, it was determined that for 2 of 4 incenter hemodialysis patients’ (Pt. #2 and Pt. #4) treatment records reviewed, the facility failed to ensure that the prescribed BFR (blood flow rate) was followed. Findings include: 1. On 2/5/2025, the facility’s policy titled, “Patient Assessment and Monitoring” (5/2023) was reviewed and included, “... Data Collection... The registered nurse will assess/re-assess any findings addressed... during treatment... 3. Machine Parameters... Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow...” 2. On 2/5/2025, the clinical record for Pt. #2 was reviewed. Pt. #2 was admitted to the facility with a diagnosis of end stage renal disease (ESRD). On 2/1/2025 and 2/4/2025, the clinical record included a physician’s order to dialyze Pt. #2 with a BFR of 350 for 3 hours. However, on 2/1/2025, Pt. #2 was dialyzed with a BFR of 300 from 10:31 AM through 12:02 PM (1 hour and 31 minutes). On 2/4/2025, Pt. #2 was dialyzed with a BFR of 250 from 10:33 AM through 12:02 PM (1 hour and 29 minutes). 3. On 2/5/2025, the clinical record for Pt. #4 was reviewed. Pt. #4 was admitted to the facility with a diagnosis of ESRD. On 12/27/2024, the clinical record included a physician’s order to dialyze Pt. #4 with a BFR of 400 for 4 hours. However, on 1/31/2025, Pt. #4 was dialyzed with a BFR of 450 from 8:33 AM through 11:30 AM (2 hours and 57 minutes). On 2/3/2025, Pt. #4 was dialyzed with a BFR of 300 from 8:01 AM through 9:01 AM (1 hour), and BFR of 450 from 9:33 AM through 11:33 AM (2 hours). 4. On 2/5/2025 at approximately 3:00 PM, findings were discussed with E #1 (Clinic Manager). E #1 stated that the dialysis prescription should be followed. E #1 added that there should be documentation in the clinical record why the prescription was not followed. B. Based on document review and interview, it was determined that for 1 of 2 home peritoneal dialysis (HPD) patients’ (Pt. #6) treatment records reviewed, the facility failed to ensure that Pt. #6 followed the dialysis prescription. Findings include: 1. On 2/5/2025, the facility’s policy titled, “Review and Documentation of Home Therapies Patient” (5/2023) was reviewed and included, “... Policy... Treatment data will be reviewed by home therapies nurse in order to... determine if patients are following their treatment plan... Review and Documentation of Health Data... Data review will be discussed with the patient and/or care partner during the patient’s regular clinic visit and concerns will be addressed and documented accordingly...” 2. On 2/5/2025, the clinical record for Pt. #6 was reviewed. Pt. #6 was admitted to the facility with a diagnosis of end stage renal disease (ESRD). Pt. #6s’ clinical record included a physician’s order of 3 exchanges of peritoneal dialysis 7 days a week. However, Pt. #6’s dialysis treatment sheets indicated that Pt. #6 had 4 exchanges of peritoneal dialysis on the following dates: 1/6/2025 through 1/9/2025 (4 days); 1/13/2025 through 1/20/2025 (8 days); and 1/22/2025 through 1/25/2025 (4 days). On 1/29/2025, home therapy nurse’s review of Pt. 6’s dialysis treatment sheets did not address concern for non-adherence to the dialysis prescription. 3. On 2/5/2025 at approximately 1:00 PM, findings were discussed with E #5 (HPD Registered Nurse). E #5 stated that the clinical record should have included documentation addressing importance of Pt. #6’s adherence to dialysis prescription.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 36774 Based on document review and interview, it was determined that for 1 of 2 home peritoneal dialysis (HPD) patients’ (Pt. #6) treatment records reviewed, the facility failed to ensure that the weight and vital signs (e.g., blood pressure, temperature, etc.) were monitored during treatments. Findings include: 1. On 2/5/2025, the facility’s policy titled, “Patient Assessment and Monitoring” (5/2023) was reviewed and included, “... to provide guidance to... direct patient care staff on assessment and monitoring patients before, during... treatments... The Registered Nurse will assess/reassess any findings ... weight... blood pressure...temperature...” 2. On 2/5/2025, the facility’s policy titled, “Review and Documentation of Home Therapies Patient” (5/2023) was reviewed and included, “... Policy... Treatment data will be reviewed by home therapies nurse... Review and Documentation of Health Data... Data review will be discussed with the patient and/or care partner during the patient’s regular clinic visit and concerns will be addressed and documented accordingly...” 3. On 2/5/2025, the clinical record for Pt. #6 was reviewed. Pt. #6 was admitted to the facility with a diagnosis of end stage renal disease. Pt. #6’s clinical record included a physician’s order of 3 exchanges of peritoneal dialysis 7 days a week. Pt. #6’s dialysis treatment records lacked documentation of weight and vital signs on the following dates: 1/6/2025 through 1/17/2025 (11 days) and from 1/19/2025 through 1/25/2025 (6 days). On 1/29/2025, the home therapy nurse’s review of Pt. #6’s dialysis treatment records did not indicate that weight and vital signs were assessed or addressed with Pt. #6. 4. On 2/5/2025 at approximately 1:00 PM, findings were discussed with E #5 (HPD Registered Nurse). E #5 stated that the clinical record should have included documentation addressing importance of documenting weight and vital signs with Pt. #6.”

“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: 39802 Based on document review, observation, and interview, it was determined that the Facility’s Medical Director (MD#1) failed to ensure that staff adhered to policies and procedures by ensuring medications were secured to prevent unauthorized access. This had the potential to affect the 52 in-center dialysis patients on census. Findings include: 1. The Facility’s policy titled, “Medication Preparation and Administration” (dated 02/06/2023), was reviewed and required, “...pre-drawn medications shall be labeled and must be kept under the preparer’s control or in a locked designated medication storage area or refrigerated, if necessary, until delivery to the appropriate patient for administration... All medications will be kept in a locked cabinet except when in use. One key to the medication cabinet will be kept by the charge nurse/team leader...” 2. During a tour of the Facility on 02/04/2025, the following was observed: - At approximately 9:44 AM, the medication drawers at the nurse’s station was unlocked and unattended by an authorized staff member. The top drawer contained vials of heparin (a blood thinner) and venofer (iron), and other oral medications. There were also 15 pre-drawn medication syringes in the drawer containing either heparin or venofer for the patients scheduled for dialysis today. The bottom drawer contained a bag of medication vials including epinephrine, diphenhydramine, and solu-medrol which are used for emergencies (i.e. anaphylaxis/allergic reaction). To note, a visitor was present in the treatment area at station #14 (nearby the medication storage area) while the staff were occupied on the other side of the unit with patients. - At approximately 9:48 AM, a syringe of heparin labeled for Pt. #1 was observed on the dialysis chair table at station #4. The patient (Pt. #1) was not yet present at the dialysis station and the syringe was left unattended by the nurse. 3. An interview was conducted with Registered Nurse (E#3) on 02/04/2025, at approximately 12:30 PM. E#3 stated that E#3 locks the medication drawer only when E#3 is off the treatment floor. E#3 stated that only nurses should have access to the medications. E#3 stated that typically E#3 does not leave pre-drawn syringes at the station; however, E#3 stated that E#3 was originally going to initiate the treatment for Pt. #1 but then one of the technicians stated that they would do it. 4. An interview was conducted with the Medical Director (MD#1) on 02/05/2025, at approximately 3:30 PM. MD#1 stated that only nurses are authorized to have access to medications and that medications should be secured.”