Fmc Midwest Dialysis

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(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:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For OPOs at § 486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 50072 Based on review of the facility’s emergency preparedness program documentation, policy and procedures, and staff interview, the facility failed to ensure the emergency preparedness program included policies and procedures addressing a system to track the location of on-duty and sheltered patients in the facility’s care during an emergency and in the event staff and patients are relocated during an emergency event. Failure to have a system in place to track patients and staff in the event of an emergency situation could potentially result in the facility’s failure to have information readily available, including information to share with other officials if needed, which could place patients at risk for adverse outcomes. At the time of the survey, the facility reported an in-center hemodialysis census of 84 patients. Findings for the facility’s emergency preparedness program include: 1. Review of the facility’s emergency preparedness documentation showed the facility lacked policies and procedures addressing a system to track the location of on-duty staff and sheltered patients in the facility’s care during an emergency and the documentation requirements if staff and patients are relocated during an emergency. 2. During interviews on 10/16/24 at 11:50 am, the Interim Clinic Manager and Quality Manager verified the required documents showing a system to track the location of on-duty and sheltered patients during an emergency are not available.”

“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: 50072 Based on review of policies and procedures, observation and staff interview, and manufacturer’s information, the facility failed to discard outdated nutritional supplements, which create risk for usage. The facility reported a census of 84 in-center hemodialysis patients at the time of the survey. Findings include: 1. The manufacturer’s information for LiquaCel Concentrated Liquid Protein indicates “3 month shelf life after opening.” 2. Review of facility policy titled “Storage of Supplies,” version 2, published 04/05/21, with the intended purpose, “To provide guidelines for storage and handling of supplies, reads in part, “All supplies must be stored in a clean, well lit, and climate controlled environment ...Supplies must be rotated First in-First out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date.” 3.Observation of the nutritional storage refigerator on 10/14/24 at 1:35 pm, showed the following: - 1 opened bottle of LiquaCel Liquid Protein grape flavor with an open date of 04/03/24; - 1 opened bottle of LiquaCel Liquid Protein grape flavor with an open date of 06/03/24; - 1 opened bottle of LiquaCel Liquid Protein ginger ale flavor with an open date of 04/04/24; - 1 opened bottle of LiquaCel Liquid Protein ginger ale flavor with an open date of 06/03/24; - 1 opened bottle of LiquaCel Liquid Protein watermelon flavor with an open date of 04/02/24; - 1 opened bottle of LiquaCel Liquid Protein peach mango with an open date of 05/21/24. 4. On 10/15/24 at 2:57 pm, RN A indicated the LiquaCel is good for three months from the open date. PCT (Patient Care Tech) C confirmed the 7 LiquaCel bottles located in the refrigerator were more than 3 months past their open date and discarded of them.”

“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: 36083 Based on documents review, observations, and interviews, the facility failed to ensure hand sanitizers used for hand hygiene were not expired during random observations at the treatment unit for 5 of 5 hand sanitizers with containers attached on the walls throughout the facility. The facility reported a census of 84 hemodialysis patients at the time of the survey. Findings include: 1. The policy titled, “Hand Hygiene” dated 11/6/23, notes purpose “to prevent transmission of pathogenic mircoorganisms to patients and staff through cross contamination.” The policy directs all staff, patients, and any other indirect care staff to follow the requirements for hand hygiene. The policy indicates hand hygiene includes using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content. The policy provides that hands will be decontaminated using alcohol-based hand rub for activities and procedures in the dialysis unit to include the following: Before and after direct contact with patients, Entering and leaving the treatment area, Immediately after removing gloves, After contact with inanimate objects near the patient, and after contact with other objects within the patient station or treatment space. The procedure for use of alcohol-based hand rub lacked guideline to ensure use of unexpired products during the hand hygiene process. 2. During observations on 10/15/24 include the following: - At 10:39 AM, registered nurse (RN) A used the alcohol-based hand sanitizer attached to the wall, on the right when entering door to the water room. The hand sanitizer showed an expiration date of 6/2024. - At 10:50 AM, Patient #8 walked towards the floor weigh scale and used the alcohol-based hand sanitizer attached to the wall, on the left side when facing the wall containing the weigh scale pad/monitor. The hand sanitizer showed an expiration date of 6/2024. - At 10:52 AM, patient care technician (PCT) F also used the same expired sanitizer after Patient #8 at the weigh scale area. - At 10:54 AM, staff educator (SE) G used the alcohol-based hand sanitizer attached to the wall behind the nurses’ station, between the door coming from the water room and the door coming from the administrative/office room. The hand sanitizer showed an expiration date of 6/2024. - At 10:55 AM, RN E used the alcohol-based hand sanitizer attached to the wall, on the right side when entering the door of the isolation room. The hand sanitizer showed an expiration date of 6/2024. - At 11:35 AM, Patient #9 was observed after a dialysis treatment, walking from the isolation room towards the floor weigh scale area. Patient #9 used the alcohol-based hand sanitizer attached to the wall, by the weigh scale (the same one used by Patient #8 and PCT F). The hand sanitizer showed an expiration date of 6/2024. - At 11:36 AM, the alcohol-based hand sanitizer attached to the wall behind station #5, showed that it expired on 6/2024. 3. During interview on 10/15/24 at 1:40 AM, RN E verified that the 5 identified alcohol-based hand sanitizers were expired. RN E also verified she used the hand sanitizer attached to the wall by the isolation room, unmindful that it expired. RN E indicated expired hand sanitizers are potentially ineffective for disinfection. RN E stated she went to check the supplies for re-filling the wall hand-sanitizer-dispensers, and found out they “are all expired” and so the facility would need to reorder. 4. During interview on 10/16/24 at 12:26 PM, the clinic manager (CM) acknowledged the importance of ensuring the potency of disinfectants such as hand sanitizers.”

“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: 50072 Based on review of policies and procedures, observation and staff interview, the facility failed to ensure opened medication vials were labeled according to facility policies. Failure to ensure labeling of opened medication vials could result in staff administering medication in which they cannot be assured of when the medication vial was opened. This could potentially lead to administering a medication in which the manufacturer can no longer guarantee the integrity, efficacy and sterility of the medication, leading to possible adverse outcomes for patients. At the time of the survey, the facility reported a census of 84 in center hemodialysis patients. Findings for observation of opened medications that demonstrated the facility failed to ensure labeling according to facility policy include: 1. Review of facility policy titled Medication Preparation and Administration, #47488, version 9, published 02/06/23, with the intended purpose, “To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control,” reads in part...”Labeling Vials- When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT (Patient Care Technician), must place the date and time the vial was opened on the medication label along with their initials. Note: To ensure all open vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened. Label any open multi-dose vial that is not used immediately and store vial accordingly.” 2. During a tour of the facility, observation of the medication cart on 10/14/24 at approximately 2:00 pm, showed an open vial approximately 1/3 full of clear fluid labeled, “Heparin Sodium Injection, USP, 10,000 units / 1 ml x 10 ml (milliliters)” lacked information that showed when the vial was opened and lacked information that showed when the vial expired after being opened. Another opened vial with clear fluid in the bottom of the vial, labeled “Heparin Sodium Injection, USP, 10,000 units / 1 ml x 10 ml (milliliters)” lacked information that showed when the vial was opened and lacked information that showed when the vial expired after being opened. 3. During an interview at 2:13 pm on 10/14/24, RN H acknowledged there were no open dates, expiration date or staff initials listed in the Heparin vials. The vials were discarded. RN H indicated multi-dose medication vials are to be labeled with open date and staff initials. 4. During the same tour of the facility and observation of the medication cart on 10/14/24 at approximately 2:00 pm, showed 3 loose unidentified pills observed lying in the top drawer of the medication cart amongst other packaged medications. One single orange pill labeled “127,” one single orange capsule labeled “674,” and one single loose orange pill labeled “APO Mid / 5,” were found with no additional labeling or packaging. 5. During an interview at 2:15 pm on 10/14/24, RN H acknowledged all medications should be stored in their respective packaging until they are prepared for the intended patient. RN H disposed of the loose pills into the trash and indicated the medications must have spilled out of their original packaging.”

“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: 36083 Based on documents review, and interviews, the facility failed to ensure reporting of occurrences in order to investigate and address for 1 of 2 incidents (facility closure) in the sample reviewed for adverse occurrence reporting and management. At the time of the survey, the facility reported a census of 84 patients. Findings include: 1. The policy titled, Patient Safety Event Reporting and Documentation, dated 2/6/23, provides staff guidelines for identifying, reporting, and documenting patient related near misses, safety events, and serious safety events. The policy also indicates staff are encouraged to report events with the understanding that event review is focused on opportunities for learning and improving the quality and safety of patient care. The policy directs staff to complete reporting in a timely manner and according to facility’s event reporting procedure. The policy indicates that patient safety events should be reviewed and analyzed by the facility’s quality assessment and performance improvement (QAPI) program. The policy further indicates a successful review of patient safety events by the QAPI committee includes: evaluation of the event; identifying trends including preventability and severity; determination of opportunities for improvement; analysis to determine what happened, why it happened, and how to prevent it from happening again; development of appropriate action plans after the root cause was identified; and ensuring complete documentation of the patient safety event in the data entry site including: final accurate patient outcome, completed event summary, factual event description, event entries and status. 2. During review of the facility’s QAPI documents, the notes section for QAPI committee meeting dated 4/24, indicated facility’s closure related to an issue with the reverse osmosis (RO) motor system. However, the events or incidents log did not identify an entry of any incident related to the facility’s closure. 3. During interview on 10/16/24 at 9:30 AM, the clinic manager (CM) stated an incident where the RO failed to work, which prompted the facility to close. The CM verified with the area technical operations manager (ATOM), who reported that the facility closed on 3/22/24, until the RO was fixed and the facility resumed operation on 3/23/24. The CM stated some patients were treated on third shift at the back-up facility, and some were rescheduled the following day. However, the CM verified there was lack of evidence to show the facility’s actions, assessment, analysis, and evaluation of the incident. The CM acknowledged the incident should have been reported as a patient safety event and addressed according to facility policy and procedure.”