Fmc - Huntington Dialysis

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility 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. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to implement its EP policies and procedures by failing to ensure required emergency drugs were on-site at all times, which had the potential to affect all 40 active patients. Findings include: 1. The facility policy #46865 “Emergency Medications, Equipment and Supplies,” dated 2/03/25, indicated the facility must keep at least two doses of Calcium Chloride (a medication used to treat cardiac arrest) and one dose of Naloxone (Narcan, a medication used to treat opioid overdose in emergency situations) on-site “to manage emergency situations.” 2. An observation of the facility’s emergency cart on 4/22/25 beginning at 10:49 AM failed to evidence the required emergency drugs Calcium Chloride and Narcan. 3. During an interview on 4/22/25 beginning at 3:05 PM, RN 1 reported the facility did not have Calcium Chloride or Narcan on the premises. 4. During an interview on 4/24/25 beginning at 11:35 AM, Clinical Manager and Administrator reported the facility was notified on 4/17/25 of the requirement to keep Calcium Chloride and Narcan on-site. Clinical Manager reported she was still working on obtaining these medications.”

“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: 48224 Based on observation, policy review and interview, the dialysis facility failed to maintain a sanitary environment within the ICHD treatment area during 2 of 2 days of ICHD treatment area observations, which had the potential to affect 40 active ICHD patients. Findings include: 1. The policy “Cleaning and Disinfecting the Dialysis Station,” last updated 9/05/23, indicated bleach solution will be stored in labeled, covered opaque containers to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air. 2. During the flash tour observation on 4/22/25 beginning at 8:55 AM, a small transparent squirt bottle of 1:10 concentration bleach solution was observed without a lid or cap and 2 containers of 1:100 concentration bleach solution were observed with the lids unsecured. 42617 3. During an ICHD treatment floor observation on 4/23/25 from 9:15 AM - 10:50 AM, a small transparent squirt bottle of 1:10 concentration bleach solution was observed without a lid or cap. Two containers with 1:100 concentration bleach solution were observed with the lids unsecured. The observation period evidenced: a. At 10:15 AM, PCT 3 took used clamps from Station #4 and placed them in a container with 1:100 concentration bleach solution. The PCT failed to cover the solution completely after placing the clamps inside. b. At 10:16 AM, PCT 2 soaked wipes in a 1:100 bleach solution then took the wipes to clean a station. The PCT failed to cover the bleach solution completely after entering the container. c. At 10:37 AM, PCT 1 soaked wipes in a 1:100 bleach solution then took the wipes to clean a station. The PCT left the container’s lid off. d. At 10:39 AM, PCT 3 soaked wipes in a 1:100 bleach solution then took the wipes to clean a small blood spill at Station 1. The PCT left the container’s lid off. 4. During an interview on 4/23/25 beginning at 12:16 PM, PCT 2 reported bleach solution was to be stored in a container with the lid on. 5. During an interview on 4/23/25 beginning at 12:39 PM, PCT 1 reported bleach solution was to be stored in a container with the lid on. 6. During an interview on 4/23/25 beginning at 12:41 PM, PCT 3 reported bleach solution was to be stored in a container with the lid on. 7. During an interview on 4/24/25 beginning at 1:25 PM, Clinical Manager and Administrator reported bleach solution was to be stored in a closed container with the lid on. When asked if the squeeze bottle used to store 1:10 concentration bleach solution was opaque, Clinical Manager reported she was unsure and stated “you can see through it.””

“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: 48224 Based on observation and interview, the dialysis facility failed to ensure all staff followed hand hygiene procedures for 3 of 5 staff members observed on the ICHD treatment floor (PCT 1, PCT 2 and CM). Findings include: 1. The facility policy “Hand Hygiene”, last updated 11/06/23, indicated hand hygiene will be performed before and after direct contact with patients, immediately after removing gloves and after contact with inanimate objects; the duration for handwashing procedure will be 40-60 seconds and patients should perform hand hygiene if able, prior to and after each dialysis treatment. 2. The facility policy “Post Treatment Fistula Needle Removal,” last updated 7/01/24, indicated when decannulating a fistula, staff should perform hand hygine and don clean gloves prior to removing the cannulation needles. After the needles are removed, the sites stop bleeding, and gloves are removed, staff will to “instruct [the] patient holding the sites to perform hand hygiene.” 3. During an observation on 4/22/25 at 9:23 AM, PCT 2 obtained labs prior to starting dialysis on Patient #9. PCT 2 carried the labs to the lab counter, removed her gloves and then washed her hands for 12 seconds. PCT 2 failed to perform hand hygiene for at least 40 seconds after removing her gloves. 42617 4. During an observation on 4/22/25 at 9:18 AM, PCT 2 removed her gloves, removed then redonned her face shield, then performed hand hygiene. The technician failed to perform hand hygiene immediately after removing gloves. 5. During an observation on 4/22/25 at 10:05 AM, PCT 1 was observed washing her hands. The technician scrubbed her hands for eight seconds then placed her hands under running water and continued to scrub, however no soap was observed. 6. During an observation on 4/22/25 at 10:28 AM, PCT 1 left Station 12, removed the glove to her right hand, entered a supply cart, obtained supplies, then donned a new glove to the right hand. The technician failed to perform hand hygiene after removing gloves and prior to donning new gloves. 7. During an observation on 4/22/25 at 10:41 AM, Clinical Manager drew up Heparin (a blood thinner) at the med station, took the medication syringe and placed it in Station 4, adjusted the patient’s papers on the treatment chair’s tray, then donned gloves. Clinical Manager failed to perform hand hygiene prior to donning gloves. 8. During an observation on 4/23/25 at 9:23 AM, PCT 1 took supplies to Station 11, placed them in the station, left the station, donned gloves at a nearby supply cart, then re-entered Station 11. The technician failed to perform hand hygiene prior to donning gloves. 9. During an observation on 4/23/25 at 9:37 AM, PCT 2 was observed washing her hands for 15 seconds. 10. During an observation on 4/23/25 at 10:37 AM, PCT 1 donned gloves, obtained bleach wipes, entered Station 12, and began to clean the station. RN 1 was performing a procedure in Station 11 and requested the technician obtain supplies. PCT 1 left Station 12, removed her gloves, obtained the requested supplies, took the supplies to Station 11, then donned new gloves and returned to cleaning Station 12. The technician failed to perform hand hygiene after removing gloves and prior to donning new gloves. 11. During an observation on 4/23/25 beginning at 12:50 PM, PCT 1 was observed decannulating Patient #13’s fistula in Station 3. The technician removed the first cannulation needle, assisted Patient in holding pressure to the site, then documented on the dialysis machine. PCT 1 then removed the second cannulation needle, failing to change gloves and perform hand hygiene. After the cannulation sites stopped bleeding, PCT 1 assisted Patient in removing their glove and walked Patient to the treatment floor exit. The technician failed to remind Patient to perform hand hygiene after Patient had held pressure to fistula cannulation sites. During an interview on 4/23/25 beginning at 1:36 PM, PCT 1 reported when decannulating a fistula, she should perform hand hygiene prior to beginning the procedure and after removing the cannulation needle. PCT 1 stated the dialysis machine was considered dirty until after disinfected with bleach. The technician stated a patient was to perform hand hygiene after holding pressure to a fistula cannulation site. PCT 1 reported she had not offered hand sanitizer or reminded Patient #13 to perform hand hygiene after Patient held pressure to the fistula cannulation sites. 12. During an interview on 4/23/25 beginning at 12:16 PM, PCT 2 reported hand hygiene should be performed after removing gloves and before donning new gloves. The technician stated hands should be washed for “60 seconds.” 13. During an interview on 4/23/25 beginning at 12:30 PM, PCT 1 reported hand hygiene should be performed between glove changes, prior to entering a station, and after leaving a station. The technician stated hands should be washed for “30 seconds” outside of running water. 14. During an interview on 4/23/25 beginning at 1:25 PM, Clinical Manager and Administrator reported staff should perform hand hygiene before donning gloves, after removing gloves, and before entering a station. Clinical Manager stated staff should wash their hands with soap and water for “45-60” seconds, scrubbing outside of running water. The administrative staff reported when decannulating a fistula, staff should change gloves and perform hand hygiene if touching the dialysis machine between removing needles.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff did not consume food or medications on the ICHD treatment floor for 1 of 1 flash tour observations. Findings include: 1. The facility policy #47685 “General Cleanliness and Infection Control Guidelines,” dated 11/04/24, indicated staff were prohibited from eating in work areas “where there is reasonable likelihood of occupational exposure.” 2. During the facility flash tour on 4/22/25 beginning at 8:55 AM, two plastic bags of candy, one opened bottle of Tums, and one opened package of cough drops were observed at the ICHD nurse’s station. 3. During an interview on 4/22/25 beginning at 3:05 PM, RN 1 reported staff food and medications were not allowed on the ICHD treatment floor. 4. During an interview on 4/22/25 beginning at 3:45 PM, Clinical Manager and Administrator reported staff food and medications were not allowed on the ICHD treatment floor.”

“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: 48224 Based on record review and interview, the medical director failed to ensure policies were followed related to medication labeling and storage for 1 of 1 patient treatment area; failed to ensure the Citric acid was labeled properly for 1 of 1 patient treatment area; failed to ensure patient lab sample was labeled properly for 1 of 1 urine sample collected (Patient #8); failed to ensure the patient treatment prescription and equipment parameters were set correctly for 1 of 2 machine setting observations on 4/22/25 (Patient #2); failed to ensure the blood flow rate (BFR), dialysate flow rate (DFR), and dialysate bath concentration were set according to physician orders for 3 of 5 patient records reviewed (Patient #1, 2 and 3) and failed to ensure the physician was notified of not meeting estimated dry weight (EDW) orders during ICHD treatment for 1 of 2 ICHD clinical records reviewed of patients not meeting EDW (Patient #5). Findings include: 1. The facility policy “Medication Preparation and Administration”, last updated 2/06/23, indicated all medications will be kept in a locked cabinet except when in use and any open multi-dose vial that is not used immediately must be labeled and stored accordingly. The policy also indicated when preparing medications if the vial is not used immediately in its entirety, the nurse or PCT, must place the date and time the vial was opened on the medication label along with their initials. 2. The facility policy “Mixing Handling and Using 2% Citric Acid”, last updated 5/05/24, indicated once mixed, 2% citric acid must be used or discarded within one month. 3. The facility policy “Nursing Supervision and Delegation”, last updated 11/06/23, indicated the RN must evaluate each patient preferably within an hour of treatment initiation to “review accuracy and completeness of treatment and patient data ... Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed.” 4. The undated facility procedure “Urine Collection for Residual Renal Function” indicated urine samples should be labeled with a bar codes whcih includes the “requisition/order, patient identification, and draw date.” The sample should then be refrigerated until shipment to the outside laboratory. 5. During the flash tour observation on 4/22/25 beginning at 8:55 AM, two unlabeled opened bottles of Heparin and three bottles of Venofer were observed sitting on the counter. The medication cabinet door was also observed open and not secured. 6. Patient #1’s ICHD treatment sheets, dated 3/25/25 to 4/15/25, were reviewed and evidenced a physician ordered BFR of 400 millilieters per minute (ml/min) and DFR of Autoflow 1.5 during the dialysis treatments. On 4/01/25, the ICHD treatment began at 4:44 AM. BFR settings were not documented until 6:35 AM. The BFR setting at 6:35 AM was 300 ml/min. At 7:07 AM, the BFR was changed to 450 ml/min for the remainder of treatment. The clinical record evidenced RN 2 verified the machine settings at 6:34 AM. RN 2 failed to adjust the BFR to the prescribed dose of 400 ml/min. The clinical record failed to evidence the physician was notified of the incorrect BFR rate. During an interview on 4/24/25 at 9:20 AM, RN 2 relayed the RN is responsible for verifying the machine settings. She also relayed Patient #1 was running on access flow testing (assesses the amount of blood flow through vascular access) for the first hour of treatment and then the BFR should have been set at 400 ml/min. She was unsure why the BFR was set incorrectly. 7. Patient #3’s ICHD treatment sheets, dated 4/03/25 to 4/19/25, were reviewed and evidenced a physician ordered BFR of 400 ml/min and DFR of Autoflow 1.5 during the dialysis treatments. On 4/03/25, the ICHD treatment began at 10:36 AM with a BFR setting of 350 ml/min for the duration of treatment. The clinical record evidenced RN 1 verified the machine settings at 10:53 AM. RN 1 failed to adjust the BFR to the prescribed dose of 400 ml/min. The clinical record failed to evidence the physician was notified of the incorrect BFR rate. On 4/08/25, the ICHD treatment began at 10:19 AM with a BFR setting of 350 ml/min for the duration of treatment. The clinical record evidenced RN 1 verified the machine settings at 10:24 AM. RN 1 failed to adjust the BFR to the prescribed dose of 400 ml/min. The clinical record failed to evidence the physician was notified of the incorrect BFR rate. During an interview on 4/23/25 at 3:18 PM, RN 1 relayed the PCT and RN were responsible for verifying machine settings within the first hour of dialysis treatment and she confirmed the clinical record did not include documentation as to why the BFR was set incorrectly on 4/03/25 and 4/08/25 and she verified the physician was not notified. On 4/05/25, the ICHD treatment began at 10:57 AM with a BFR setting of 400 ml/min. At 1:04 PM, the BFR setting was changed to 350 for the remainder of treatment (one hour and 20 minutes). The clinical record evidenced RN 2 verified the machine settings at 1:32 PM. RN 2 failed to adjust the BFR to the prescribed dose of 400 ml/min. The clinical record failed to evidence the physician was notified of the incorrect BFR rate. During an interview on 4/24/25 at 9:20 AM, RN 2 relayed she was unsure why the BFR was lowered during treatment and confirmed the clinical record did not include any documentation as to why the BFR was changed. She also confirmed the physician was not notified. 42617 8. Patient #2’s ICHD treatment sheets, dated 4/10/25 to 4/22/25, were reviewed and evidenced a physician ordered BFR of 400 ml/min. The dialysate bath concentration was ordered to include 1.0 milliequivalents per liter (mEq/L) of potassium for the first hour of treatment, then switch to 2.0 mEq/L of potassium for the remainder of treatment, and a bicarbonate rate of 32 mEq/L. During an observation on 4/22/25 beginning at 12:28 PM, PCT 2 verified Patient #2’s dialysis prescription and machine settings in Station 7 with the surveyor. Patient had completed approximately 3 hours and 50 minutes of treatment. Patient’s bicarbonate rate was set to 37 mEq/L instead of the ordered 32 mEq/L. PCT 2 was unsure of the reason the bicarbonate setting did not match Patient’s prescription. During an interview on 4/23/25 beginning at 1:15 PM, RN 1 reported she verified each patient’s dialysis machine settings against the prescription while the PCT started the treatment. RN 1 reported she was unaware Patient #2’s bicarbonate rate did not match the prescription on 4/22/25. The ICHD treatment sheets for the runs on 4/10/25, 4/12/25, 4/15/25, and 4/17/25 failed to evidence Patient’s dialysate bath concentration included 1.0 mEq/L of potassium for the first hour of treatment. The ICHD treatment sheet for the run on 4/19/25 evidenced the treatment began at 8:50 AM with a BFR setting of 450 ml/min. The record evidenced RN 2 verified the machine settings at 9:24 AM. RN 2 failed to adjust the BFR to the prescribed dose of 400 ml/min, and Patient’s BFR remained at 450 ml/min for the rest of the treatment. During an interview on 4/24/25 beginning at 9:15 AM, RN 2 reported she was unsure of the reason Patient’s BFR was higher than the prescribed rate on 4/19/25. The nurse stated the treatment sheet should include documentation that Patient’s dialysate bath concentration included 1.0 mEq/L of potassium during the first hour of treatment. 9. Patient #5’s ICHD treatment sheets, dated 4/05/25 to 04/22/25, were reviewed and evidenced a physician-ordered EDW of 63.1 kilograms (kg). On 4/08/25, Patient’s pre-treatment weight was 69.3 kg. Patient’s post-treatment weight was 67.5 kg, which was 4.4 kg above the ordered EDW. The treatment sheet failed to evidence Patient’s physician was notified Patient’s post-treatment weight was above the EDW. On 4/10/25, Patient’s pre-treatment weight was 69.9 kg. Patient’s post-treatment weight was 66.6 kg, which was 3.5 kg above the ordered EDW. The treatment sheet failed to evidence Patient’s physician was notified Patient’s post-treatment weight was above the EDW. On 4/15/25, Patient’s pre-treatment weight was 68.9 kg. Patient’s post-treatment weight was 66.1 kg, which was 3.0 kg above the ordered EDW. The treatment sheet failed to evidence Patient’s physician was notified Patient’s post-treatment weight was above the EDW. On 4/22/25, Patient’s pre-treatment weight was 68.5 kg. Patient’s post-treatment weight was 66.8 kg, which was 3.7 kg above the ordered EDW. Patient left the treatment 45 minutes early due to an appointment. The treatment sheet failed to evidence Patient’s physician was notified Patient’s post-treatment weight was above the EDW. During an interview on 4/24/25 beginning at 11:12 AM, RN 2 reported the physician or physician assistant (PA) should be notified if a patient’s post-treatment weight was 0.5 kg above the EDW. RN 2 reported the physician or PA notification should be documented in the clinical record, however she was unable to find documentation of physician/PA notification for the above dates. During an interview on 4/24/25 beginning at 11:19 AM, RN 1 reported there was no set value on when to report a post-treatment weight that was greater than the EDW. She stated she would notify Patient’s PA for any difference from the EDW. When asked where this was documented in the clinical record, RN 1 stated she had been working to include this in her documentation, but was unsure if she had documented the PA notification for the above dates. 10. During an interview on 4/24/25 beginning at 1:25 PM, Clinical Manager and Administrator reported the PCT was responsible for entering the dialysis machine settings according to the prescription and the nurse was responsible for verifying the settings matched the patient’s prescription. The nurse should verify the settings within the first hour of treatment. The administrative staff reported the reason the dialysis prescription was not followed should be documented. 11. During an ICHD flash tour on 4/22/25 beginning at 8:55 AM, one jug of mixed 2% citric acid failed to evidence the date of mixing. During an interview on 4/22/25 beginning at 12:36 PM, PCT 2 reported she opened the facility that day. The 2% citric acid had been mixed on 4/21/25. The technician confirmed the jug of 2% citric acid was not labeled with the date it was mixed. During an interview on 4/24/25 beginning at 1:25 PM, Clinical Manager and Administrator reported citric acid should be labeled with the date it was mixed. 12. During a tour of the ICHD laboratory room on 4/22/25 beginning at 12:55 PM, one urine specimen tube and one urine collection container in the laboratory refrigerator failed to evidence a label which included the patient name and date the sample was obtained. During an interview on 4/22/25 beginning at 3:05 PM, RN 1 reported Patient #8 had brought in the urine collection container earlier that day and the nurse had notified Clinical Manager. The nurse was unsure if the urine collection container was labeled. During an interview on 4/22/25 beginning at 3:40 PM, Clinical Manager reported she had obtained the urine in the specimen tube from the collection container Patient #8 provided on 4/22/25. Clinical Manager stated she had failed to label the specimen tube or collection container prior to placing the samples in the laboratory refrigerator.”