Fmc Harlingen

“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: 35561 Based on observation, interview, and review of the facility’s policy, the facility failed to ensure two of three Patient Care Technicians (Patient Care Technician (PCT)2, PCT3) and two of two Licensed Vocational Nurses (Licensed Vocational Nurse (LVN)1 and LVN2) who were observed during care delivery, implemented proper infection control measures during initiation of dialysis. Failure to use recommended infection control practices increases the risk for cross contamination and has the potential to expose patients and staff to blood-borne pathogens. This deficient practice had the potential to affect 71 facility patients currently receiving treatment in the dialysis unit. Findings include: On 04/17/24 at 11:30 AM, LVN2 was observed initiating hemodialysis for an unidentified patient with a peripheral access at Station 7. LVN 2 was observed cleansing the cannulation sites with an alcohol pad in one quick swipe lasting no longer than two seconds. Next, before cannulation, LVN2 reassessed the flow of the access by placing their fingers over the access multiple times in the same areas that had been disinfected. After palpation, LVN2 then proceeded to cannulate the access without further cleansing. On 04/17/24 at 12:10 PM, PCT 3 was observed initiating hemodialysis for an unidentified patient with a peripheral access at Station 20. PCT3 was observed cleansing both of the cannulation sites together with an alcohol pad for no longer than five seconds. Next, before cannulation, PCT3 assessed the flow of the access by placing their fingers over the access multiple times in the same areas that had been disinfected. PCT3 then proceeded to cannulate the access without further cleansing. On 04/19/24 at 9:40 AM, PCT2 was observed initiating hemodialysis for an unidentified patient with a peripheral access at Station 13. PCT2 was observed cleansing both of the cannulation sites together with an alcohol pad for no longer than five seconds. PCT2 then proceeded to cannulate the access without further cleansing. On 04/19/24 at 10:50 PM, LVN1 was observed initiating hemodialysis for an unidentified patient with a peripheral access at Station 3. LVN1 was observed cleansing both of the cannulation sites with an alcohol pad for no longer than 10 seconds. LVN1 then proceeded to cannulate the access without further cleansing. On 04/19/24 at 11:25 AM, LVN2 was observed initiating hemodialysis for an unidentified patient with a peripheral access at Station 7. LVN2 was observed cleansing both of the cannulation sites with an alcohol pad for no longer than five seconds. Next, before cannulation, LVN 2 assessed the flow of the access by placing their fingers over the access multiple times in the same areas that had been disinfected. LVN2 then proceeded to cannulate the access without further cleansing. When questioned about access disinfecting, LVN2 stated that the access sites should be cleaned for “several seconds” and that they should be allowed to dry. When asked if the access sites should be cleaned at the same time, or separately, LVN2 stated “it depends on where the access is.” During an interview on 04/19/24 at 3:50 PM, these findings were discussed with the Clinical Manager and the Director of Operations Director, at which time the Clinical Manager responded, “These observations do not meet the requirements of our infection control policy.” Review of the facility’s policy titled, “Access Assessment and Cannulation,” dated 07/05/22, stated “Disinfect cannulation site as follows: 70% isopropyl alcohol pad: using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating .... Perform skin antisepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection. Note: This method minimizes the risk of contaminating the second site while cannulation the first site.””

“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: 35561 Based on observation, interview, and review of the facility’s policies and procedures, the facility failed to ensure that solutions used for cleaning and disinfection of contaminated equipment surfaces was prepared properly and according to facility policy for three of three bleach solutions being used in the treatment area on one of two survey days. Failure to use recommended infection control practices increases the risk for cross contamination and has the potential to expose patients, staff, and others to blood-borne pathogens. This deficient practice had the potential to affect all 71 patients receiving treatment in the dialysis unit. Findings include: Observation of the treatment floor on 04/19/24 at 11:30 AM revealed the container of bleach solution, located at the sink across from Station 13, used for disinfecting dialysis stations and non-disposable equipment was dated 04/17/23. The container of bleach solution, located at the sink across from Station 9, did not have a legible date of mixing documented on it. The container of bleach solution, located at the sink across from Station 20, also did not have a legible date of mixing documented on it. During a tour of the treatment floor on 04/19/24 at 11:50 AM, these findings were presented to and confirmed by the Clinical Manager who responded, “This is not correct. Our policy is to discard the beach and mix new daily and document it. You can’t even read some of these dates.” Review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/23, stated “After use, any non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach or EPA (Environmental Protection Agency) registered disinfectant ... Externally disinfect the dialysis machine with 1:100 bleach solutions after each treatment.” Review of the facility’s policy titled “Mixing Bleach,” dated 08/25/20, stated “Discard solution daily at end of treatment day or more often if needed.””

“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: 35561 Based on observation, interview, and review of the facility’s policies and procedures, the facility failed to ensure one of one Registered Nurses (Registered Nurse (RN)3) who was observed during the administration of intravenous medications, implemented proper infection control measures during medication preparation. Failure to use recommended infection control practices increases the risk for cross contamination and has the potential to expose patients to blood-borne pathogens. This deficient practice had the potential to affect 71 facility patients currently receiving treatment in the dialysis unit. Findings include: On 04/19/24 at 11:40 AM, RN3 was observed preparing intravenous medications for an unidentified patient. After checking the name of the medication, RN3 was observed inserting the sterile needle of the syringe through the diaphragm of the multiuse medication vial, which had been previously opened and used, without cleansing the top of the vial. After withdrawing the correct dose of medication, RN3 was observed administering the medication intravenously to a patient at Station 14 who was undergoing a dialysis treatment. When questioned, RN3 stated “I know we’re supposed to disinfect the top of the vial before we draw medications, I just forgot to do it this time.” During an interview on 04/19/24 at approximately 2:30 PM, these findings were discussed with the Clinical Manager at which time the Clinical Manager acknowledged that this practice presented a risk for cross contamination and stated, “our policy is to always cleanse the top of multidose vials before using them.” Review of the facility’s policy titled “Medication Preparation and Administration” dated 02/06/23, stated “Cleanse the diaphragm 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.””

“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: 18750 Based on observation, interview, and facility policy review, the facility failed to ensure the lavender top vacutainers used for complete blood count were not expired for 290 of 290 tubes found in the lab area and in the supply area. The findings had the potential to cause false blood results in the blood work for 71 in center hemodialysis patients and one home hemodialysis patient. Findings include: Review of the facility policy titled, “Expiration Dates Sterile Supplies” date of 07/05/12, revealed, “Purpose: The policy provides guidance on checking expiration dates to assure that sterile supplies are taken out of circulation by the expiration date. . . Policy. . . items will be checked before use to ensure that they have not expired. Appropriately dispose of items that have reached the expiration date. . .” Review of the facility policy titled, “Storage of Supplies” date of 04/05/21, revealed, “Purpose: The purpose of this policy is to provide guidelines for storage and handling of supplies. . . Supplies must be rotated first in-First Out (FIFO) to ensure products maintain quality and to do not expire. Appropriately dispose of items that have reached the expiration date. . .” During a tour of the facility’s treatment area on 02/17/24 at 9:45 AM, area one open tray of 69 lavender top tubes and another open tray with 30 tubes were found in the lab area with an expiration date of 02/01/24. The Clinical Manager and Director of Operations were present and agreed the tubes were expired. As the tour continued at 9:55 AM, two trays of 100 each of the lavender top tubes were in the supply area with the expiration date of 02/01/24. The Clinical Manager and Director of Operations were present and agreed the tubes were expired. During an interview on 04/17/24 at 10:15 AM, the Clinical Manager was asked about the expired tubes. The Clinical Manager stated, “I was very surprised to find the expired tubes. We try to watch how many we order just for that reason. There should not have been any expired tubes in the lab area or the supply room.””

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 18750 Based on record review, interview, and facility policy review, the facility failed to include in Quality Assessment and Performance Improvement (QAPI) an event of which one of one patient (Patient (P)1) had to be transferred to the hospital while at the facility receiving dialysis. The findings had the potential to prevent QAPI to review and minimize and limit the number of occurrences of 71 in center hemodialysis patients that could be transferred to the hospital. Findings include: Review of the facility policy titled, “Quality Assessment and Performance Improvement Program” with a published date of 05/02/22 revealed, “Purpose: The policy outlines the purpose, structure, and required activities of the facility Quality Assessment and Performance Improvement (QAPI) Program. . .Policy. . .Hemodialysis patients (in-center and home) and peritoneal dialysis patients should be reviewed separately since factors affecting their clinical outcomes may be different; both groups of patients must be reviewed on an ongoing basis. QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes. . .” Review of P1’s medical record revealed an admission date of 06/26/20 with end stage renal disease, congestive heart failure, and a seizure disorder. Further review of P1’s medical record revealed on 11/24/23, P1 had to be transferred to the hospital after experiencing a seizure. During review of the QAPI activity for the last year, there was no mention of the episode in which P1 was transferred to the hospital. During an interview on 04/19/24 at 3:05 PM, the Clinical Manager was asked if P1’s hospital transfer should have been reviewed during the December 2023 QAPI meeting. The Clinical Manager stated, “Yes. That was an adverse event, and it should have been reviewed during the December QAPI. The patent is only on the transfer sheet, and it was not brought across to QAPI because the patient was also admitted after that episode.””