Fmc - Botsford Park

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 36887 Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment for providing dialysis; failed to perform hand hygiene; and failed to prepare, administer, and store medications according to facility policy and acceptable standards of practice resulting in the potential for the spread of infectious agents to all patients served by the facility. Findings include: See Specific Tags: V-111 Failure to maintain a clean and sanitary environment V-113 Failure to change gloves and perform hand hygiene V-117 Failure to separate clean and dirty items/areas V-143 Failure to practice asceptic techniques with medications”

“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: 36887 Based on interview and record review, the facility failed to have emergency supplies and equipment available for immediate use and failed to complete daily checks on emergency equipment resulting in the potential for poor patient outcomes. Findings include: On 5/7/2024 at 1044 during the initial tour of the home program, the AED (automated external defibrillator) was opened and found to have a pad attached that expired 7/28/2023. This finding was confirmed by Manager Staff J at the time of discovery. On 5/7/2024 at 1047, review of the “AED Daily Inspection Log” from October 2023-present revealed no checks were done on the following dates: 11/23/2023, 11/24/2023, 11/27/2023, 12/15/2023, 12/18/2023, 12/28/2023, 12/29/2023, 1/23/2024, 1/25/2024, 1/26/2024, 1/29/2024, 1/30/2024, 1/31/2024, 2/8/2024, 2/9/2024, 2/12/2024, 3/1/2024, 3/4/2024, 3/5/2024, 3/6/2024, 3/7/2024, 3/8/2024, 3/11/2024, 3/12/2024, 3/13/2024, 3/14/2024, 3/15/2024, 3/18/2024, 3/19/2024, 3/20/2024, 3/21/2024, 3/22/2024, 3/25/2024, 3/26/2024, 3/27/2024, 3/28/2024, and 3/29/2024. On 5/7/2024 at 1050, Staff J stated the log for equipment checks should be done daily when the facility was opened. Facility policy “Use of Zoll Automated External Defibrillator (AED) Plus” published 12/7/2016 states, “A daily inspection log must be maintained to ensure that the GREEN check symbol (check) appears in the STATUS INDICATOR WINDOW and the unit does not emit a beeping/chirping tone...AED checks will be documented on the Zoll AED Plus Daily Inspection Log.””

“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: 32000 Based on observation, interview, and record review, the facility failed to regularly monitor for a sanitary environment to minimize the transmission of infectious agents within the dialysis unit and its support spaces, potentially effecting 73 patients receiving in-center hemodialysis treatment, and 14 patients receiving home hemodialysis treatment, out of the facility’s total census of 104 patients, resulting in an increased potential for infections. Findings include: On 5/7/2024 between 0941, and 1018, upon tour of the treatment floor with Area Technical Operations Manager, staff F, and Regional Technical Operations Manager, staff Z, the chase water boxes at patient treatment chair stations number 6, 11, 12, 13, 15, and 19 were observed discolored, with an accumulation of debris, and a crystal like build up. On 5/7/2024 at 1010, the surveyor inquired with staff F on the frequency in which these areas are expected to be cleaned to which they stated, “the nurses should clean the water boxes after each patient, and the maintenance staff does monthly cleaning and pressure checks on the boxes”. At this time the surveyor requested a copy of these cleaning policies to review. On 5/9/2024 at 0902, record review of a document titled, Generic Acid Delivery System -PM- Monthly 1, dated, 5/7/2024, revealed the facility has policies in place to maintain the water boxes in a clean, sanitary, and fully functional state. On 5/7/2024 at 13:56, the isolation room’s designated soiled sink was observed with dark black discoloration on the sides and bottom of its basin, and its perimeter caulking cracked and missing in sections. At this time, upon interview with Biomedical Technician, staff G, on the current state of the sink they stated, “I don’t remember a work order being placed for this, but I will add it to my list to be corrected”. On 5/9/2024 at 0923, upon tour of the home hemodialysis portion of the facility with Home Therapy Program Manager, staff J, the designated clean supply storage closet was observed with an accumulation of dust and debris on the floor, missing ceiling tiles, a staff members jacket, a fabric cover bench, and open box of ceiling tiles, a metal hinged foot locker, and a variety of information technology (IT) equipment co-mingled with ready for use clean supply items. On 5/9/2024 at 0927, upon interview with staff J on the current state of the room they stated, “we need to get things that aren’t necessary out of this room and fix our ceiling and IT cords. We can raise up our bottom shelves so it’s easier to clean underneath, and make sure no utility items are stored in here. I remember seeing a ladder in here the other day”. 47415 On 5/7/24 between 1000-1230 and between 1400 -1500 observations on the treatment floor revealed the following: Trash cans located at both ends of the treatment floor were overfilled; and scattered debris (pieces of supply wrappers and used gloves) noted on the floor around the trash cans and at various stations (occupied and unoccupied). Debris which appeared to be insects noted in the ceiling light fixtures throughout the treatment floor, and high dust was noted on top of the Hellmer refrigerator located in an area dedicated to storage on the treatment floor. Dust was also noted on the windowsills behind stations #11 and 12. At 1105, a syringe with clear liquid was observed on a windowsill behind station #12. Staff nurse, Staff I, was asked for assistance. When the nurse picked up the syringe she identified the patient on the label. Syringe was dated day prior (5/6/24) and had Heparin medication in it. When asked if this was an appropriate place for the unused medication from the day prior, Staff I stated “no”. Nurse proceeded to dispose the syringe. At the time of observations staff currently on unit confirmed the above observations and were asked how the trash gets emptied and staff stated they have a contract service that does it, they do not do it. Interview with clinical manager Staff A revealed the staff on the treatment floor is responsible for general cleaning needs during patient treatment times, and a contracted service comes in daily (evening) to do a deep clean of the treatment floor and other areas of the facility. Facility Policy titled, “General Cleaning and Infection Control Guidelines” dated 2/7/2022, indicated: “All areas must be kept clean and organized, including but not limited to the treatment area...Walkways must be kept clear of debris and free of clutter...Facility staff are accountable for cleaning rooms/areas not assigned to contract staff.””

“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: 47415 Based on observation, interview, and record review, the facility failed to ensure staff performed hand hygiene between all glove changes and when going from dirty areas to clean area, per facility policy, resulting in the potential for spread of infectious agents to all patients at the facility. Findings include: Observations of hand hygiene on 5/7/24: At 1038 Patient care technician (PCT), Staff L, was observed cleaning station #16. Staff was wearing gloves during cleaning. After whipping the station’s surfaces Staff L took off gloves, proceeded to a nurses’ station, donned new clean gloves, took the next patient’s clean supplies and proceeded back to the station to set up a new treatment. No hand hygiene was observed in between changes of gloves. After hanging the new fluid bag and priming the tubing, Staff L went to the station #22 to stop the alarm on the dialysis machine. Staff L was wearing the same pair of gloves. After addressing needs at station #22, Staff L took the gloves off, touched her face and a face shield, picked up more clean supplies and placed them on a side table at station #16. No hand hygiene was performed by the staff. Further, Staff L proceeded to put new gloves on, went to station #22 and touched the dialysis machine. She disposed her gloves and went on to the nurses’ station. There she took 2 new syringes, filled them with medication, labeled syringes and went to station #16 where she placed syringes on a chair side table. No hand hygiene was observed in between gloves disposal and medication handling. At 1130 PCT Staff P was observed setting up a treatment station #28, which included touching all surfaces of the hemodialysis machine, then immediately opened a clean supply set on the bedside table without first doffing gloves and performing hand hygiene. At 1155, at station 28, Staff P was observed assessing a patient’s access site by touching the patient’s skin with gloved hands, then removing gloves and immediately grabbing a new pair of gloves from the glove box without performing hand hygiene. Staff P was questioned (on the above) and the requirements for hand hygiene and glove use when going from dirty to clean, and after removing gloves and she stated she should have washed her hands. At 1400 PCT Staff L was observed removing gloves after discontinuing a central venous catheter from the hemodialysis machine at station 19, she then immediately walked over to a nearby glove supply box and grabbed a new pair of gloves without performing hand hygiene. Staff L was asked if it was acceptable practice to doff gloves and grab new ones from a clean box of gloves without performing hand hygiene, and she stated she should have washed her hands. At 1205, LPN Staff I was observed responding to an alarm on the dialysis machine, at station 26, touched the front of machine, removed her gloves and donned new gloves without performing hand hygiene. Then Staff I proceeded to assess the patient’s graft site, which included removing tape and manipulating needles. Staff I asked if she should have performed hand hygiene before she donned new gloves, and she stated she was not aware she needed to, but it makes sense. The facility policy titled “Hand Hygiene” dated 11/6/23, states: “All staff... must follow the same requirements for hand hygiene...Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water hand hygiene... before and after direct contact with patients....immediately after removing gloves....””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 47415 Based on observation, interview, and record review, the facility failed to ensure the administration of medication without potential for cross-contamination, resulting in the potential for transmission of infectious agent to the 29 patients currently receiving dialysis at the facility. On 5/7/24 at 1055 at station #7, Staff U was observed taking 2 filled medication syringes (Iron and Mircera) and setting them directly on top of the hemodialysis machine (HD), using the HD top as a table, while preparing access site for administration. At 1100 Staff U was quiered on the use of the machine as table, and if the top of the HD was considered contaminated/dirty, and Staff U stated the machine is cleaned between each patient for the current patient in the chair and he/she is using it. Interview/discussion on 5/7/24 at approximately 1430 with Clinical Manager Staff A, regarding the above practice confirmed this is not an acceptable. Facility policy Titled “Medication Preparation and Administration”, dated 2/6/23 states, “The following steps must be taken to ensure infection control...medication will be prepared in a clean work area away from dialysis patient stations, common mediation carts and trays shall not be used...””

“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: 47415 Based on observation, interview, and record review, the facility failed to ensure medications ready for use were drawn up and labeled according to facility policy, resulting in the potential for poor patient outcomes to the 29 patients currently receiving treatment. Findings include: On 5/7/24 at 0930, Staff V was observed removing a Zofran injection medication from a vial into a syringe. Staff V did not swab the vial with an alcohol pad prior to withdrawing the contents. On 5/7/24 at 0950, prior to the patient arriving to the chair, at the medication preparation area, Staff W was observed removing heparin 2 milliliters (mLs) from a vial into a syringe. Staff W prepared another syringe containing 2 mLs of heparin. Staff W brought both syringes to Station 5, and placed one syringe on the dialysis machine and placed the other syringe on the tray next to the patient’s chair. Both syringes were unlabeled. Staff W walked away from the station. When asked why other syringes in the facility were labeled prior to administration, while these were unlabeled, Staff W said yes these should be labeled and proceeded to label the syringes. On 5/7/24 at 1030, 2 -10 mL syringes and 2- 5 mL syringes unattended at the medication preparation area, containing heparin were labeled with drug name, concentration and patient name, no documentation of time or initials of person drawing up medication was on any of the 4 syringes. Surveyor was unable to determine how long they were drawn up for. At the time of observation, Patient Care Tech (PCT) staff on unit stated they draw them up just before it is needed for patient, and they should be timed and initialed. Interview with Clinical Manager Staff A and Charge Nurse Staff B confirmed medication are good for 4 hours after being drawn up and label should include time and date. The facility Policy titled Medication Preparation and Administration, dated 2/5/2023, under Labeling Reconstituted Medication Solutions and Syringes: “All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time and initials of the person who prepared the medication. Filled syringes do not have to be labeled if drawn up and administered immediately. These unlabeled, filled syringes must not be placed down at any time. Only one unlabeled, filled syringe can be drawn up and administered at one time.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 36887 Based on record review and interview, the facility failed to recognize 1 (#11) of 2 unstable patients reviewed resulting in the potential for unrecognized, unmet patient needs and poor patient outcomes. Findings include: During the patient selection process for medical record review in the home program on 5/7/2024 at 1400, the hospitalization log was reviewed and it was noted that P-11 had been hospitalized as follows: 2/23/2024 thru 3/21/2024 and 3/21/2024 thru 4/11/2024 for a below the knee amputation (BKA). On 5/8/2024 at 1151, review of the medical record for P-11 revealed the comprehensive interdisciplinary assessment (CIA) for the 4/25/2024 plan of care for the interdisciplinary team (IDT) revealed each assessment (Physician-4/25/2024, Nurse-4/18/2024 , Dietician-4/24/2024, and Social Worker-4/18/2024) indicated the reason for the assessment was “Monthly CIA (unstable).” Further review of the medical record revealed the plan of care dated 4/25/2024 indicated P-11 was stable and the next plan of care was scheduled for 4/25/2025. On 5/8/2024 at 1226, Home Manager Staff J was queried as to if P-11 should have been made unstable. Staff J stated, “He was out for hospitalization but was not recognized as being unstable. I would agree he should be unstable because he was in the hospital for almost 30 days.” Staff J looked on her computer for past plans of care and then stated, “He has always been stable.” On 5/8/2024 at 1300, review of the “Monthly Stable Versus Unstable Patient Report” dated 2/27/2024 indicated P-11 was in the hospital. P-11’s name was not present on the 3/21/2024 report and the 4/25/2024 report indicated P-11 was stable. Facility policy #45283 titled “Comprehensive Interdisciplinary Assessment and Plan of Care” published 7/3/2023 states, “The following are unstable criteria: Extended or Frequent hospitalizations: a. Hospitalization of more than 15 dyas with discharge occurring within the last 30 days, or b. More than 3 admissions in the last 30 days...””

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 36887 Based on record review and interview, the facility failed to ensure 4 (#1,4,5,14) of 8 in-center patients reviewed for plans of care had signatures present on the day of the plan of care meeting by interdisciplinary team members who attended the plan of care meeting resulting in the potential for unrecognized, unmet patient needs and poor patient outcomes. Findings include: On 5/8/2024 at 1443, review of the medical record for P-4 revealed the plan of care (POC) dated 2/2/2024 indicated the nurse, Staff B, had attended in person; however, she signed the POC on 3/11/2024. On 5/9/2024 at 0930, review of the medical record for P-5 revealed the POC dated 2/13/2024 indicated the physician extender had attended in person; however, there was no signature. Additionally, the physician oversight was also missing a signature. On 5/9/2024 at 1055, Facility Administrator Staff A was queried as to why staff signatures were late or missing on the plans of care when indicated they were present in person. She stated, “I don’t know why it wouldn’t be signed if they were here in person.” Facility policy #45283 titled “Comprehensive Interdisciplinary Assessment and Plan of Care” published 7/3/2023 states, “The Comprehensive Interdisciplinary Assessment and Plan of Care must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum the patient or patient’s designee, a registered nurse, the patient’s attending physician( or physician extender where allowed by State regulations), qualified master’s degree level social worker and qualified registered dietitian. The Comprehensive Assessment and Plan of Care (adult patient) must be completed electronically in the patient’s medical record. The Plan of Care should be signed at the time of the interdisciplinary team meeting or if attending remotely, the care plan must be signed by the IDP (sic) member within 30 days of the interdisciplinary team meeting... The Attending Physician reviews CIA [comprehensive interdisciplinary assessment] and indicates with his/her signature on the POC their oversight of the patient’s Plan of Care within 30 days.” 47415 On 5/8/2024 at 1000 review of the medical record for P-1 revealed the plan of care (POC) dated 4/11/23 indicated the Registered Nurse (RN) attended in person; however, there was no signature.. On 5/9/2024 at 1130 review of the medical record for P-14 revealed the plan of care (POC) meeting dated 3/12/24 indicated the Registered Nurse, Social Worker, and Physician Extender attended in person, however, there was no signatures, and POC meeting dated 5/7/24 indicated the physician extender had attended in person; however, there was no signature.”

“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: 36887 Based on record review and interview, the medical director failed to ensure staff followed policy and procedure for 1) the initial nursing assessment for 1 (#4) of 2 new patients reviewed and 2) blood flow rates and/or dialysate flow rates being documented appropriately on the treatment sheets for 1 (#13) of 4 in center patients reviewed for treatment monitoring, resulting in the potential for unrecognized, unmet patient needs and poor patient outcomes. Findings include: On 5/8/2024 at 1443, review of the medical record for P-4 revealed his first date of treatment was 12/4/2023. Review of the initial nursing assessment revealed it was completed 12/4/2023 at 0800. Review of the initial treatment sheet revealed P-4 was initiated on treatment at 0626. On 5/8/2024 at 1530, Facility Administrator Staff A stated her staff “always does the assessment before they (the patient) go on treatment.” Facility policy #45283 titled “Comprehensive Interdisciplinary Assessment and Plan of Care” published 7/3/2023 states, “A registered nurse must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs.” 47415 On 5/8/24 at 1400, review of the medical record (treatment sheets) for P-13, dated 4/24/24 - 5/6/24 revealed the blood flow rate (BFR) and dialysis flow rate (DFR) was not documented consistently with treatment monitoring every 30 (not to exceed 45) minutes, per policy, findings as follows: 4/26/24 Treatment start time was 0602, BFR and DFR not documented with treatment monitoring at 0700, 0730, 0800. 5/1/24 Treatment start time was 0531, BFR and DFR not documented with treatment monitoring at 0600, 0630, 0700 ,0730, 0800, 0830. 5/3/24 Treatment start time was 0531, BFR and DFR not documented with treatment monitoring at 0630, 0700, 0830,0900,0930. On 5/9/24 at approximately 1530 interview with Medical Director revealed that he expected staff to follow the policies and procedures of the facility. Facility policy titled “Patient Assessment and Monitoring”, dated 5/1/23 states, document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes..””