Fmc - St Johns

“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: 36887 Based on observation, interview, the facility failed to separate clean supplies/equipment from dirty areas resulting in the potential for spread of infectious agents to the 13 patients currently dialyzing on the treatment floor. Findings include: On 5/1/2024 at 1015, Staff K was observed entering Station #10 with syringes containing Heparin and set the syringes on the chairside table. It was noted the chairside table did not have a barrier sheet present. Staff K walked back to the nurse’s station and obtained the patient’s initiation “pack” containing supplies needed for initiating dialysis for the patient. Staff K set the pack on the chairside table next to the Heparin syringes. On 5/1/2024 at 1047, Staff J was observed putting new blood tubing onto the dialysis machine in preparation for a patient to be dialyzed. Upon opening the packaging, Staff J removed the tubing and set it on top of the packaging. One of the tailed ends off of the tubing was resting on the arm of the treatment chair. On 5/1/2024 at 1054, Registered Nurse Staff L was queried as to if a barrier should be used on the chairside table before clean supplies or equipment was laid down to which she stated a barrier should be used and a barrier sheet was put into the initiation packs for that reason. Additionally, Staff L stated if the bloodline tubing touched the chair in any way, it should be replaced and a different set should be used. Medical Director Staff N was informed of the above observations on 5/2/2024 at 1153 and stated she would expect a barrier to be used prior to placing clean items on the chairside table. A policy was requested regarding separation of clean supplies/equipment from dirty areas but was not provided prior to end of survey. 28042 On 5/1/2024 at 1050, Staff K was observed placing supplies on the chairside table of Station #8 to prepare for removal of dialysis needles and lines from a fistula. Staff K was observed placing two gauze pads, saline filled syringes, tape, and alcohol pads directly on the chairside table. It was observed the chairside table did not have a barrier sheet present. On 5/1/2024 at 1055, PCT Staff K was asked if she knew what the facility policy stated in regards to using a a barrier between the surface and clean supplies or equipment to which she stated she believed the policy stated a barrier always goes under supplies, and that is why supply packs are wrapped in two barrier sheets.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 39083 Based on interview and record review, the facility failed to collect microbial samples before the water system disinfection process, resulting in the potential for inaccurate microbial monitoring, affecting all patients in the facility. Findings include: During an interview on 4/30/24 at 10:37 AM, Biomed Staff “O” was queried on the timeframe in which microbial samples are drawn in relation to the disinfection process and stated that microbial samples are taken a day after disinfection. At this time, Area Technical Operations Manager (ATOM) Staff “P” stated that the proper method was to draw microbial samples before the system is disinfected. Biomed “O” then stated that they weren’t aware that [microbial samples] needed to be before the disinfection process. ATOM “P” then stated that he didn’t catch that the microbial samples weren’t being done until after disinfection of the water system. According to the facility’s policy titled, “Microbiological Monitoring of Central Water and Concentrate Mixing and Delivery Systems,” published 03/16/2023, it notes, “... Scheduled Sampling, After successful baseline sampling, microbiological samples will be collected no less than monthly. - Samples will be collected prior to disinfection and within 96 hours of disinfection. - Collection of samples post disinfection are not required unless directed by FKC Water action plans. - Automated systems that routinely disinfect more than one time during a calendar month, such as heat disinfection systems, are only required to be sampled once a month. Sample should be taken as close as practical but before the start of a disinfection cycle.” According to the facility’s “QAI TECHNICAL REPORT - CLINIC 2046 - MARCH/ 2024,” it notes the RO system disinfections occurred on 3/4/24, 3/11/24, 3/18/24, and 2/25/24. The pre-disinfection samples collection date was noted on 3/21/24.”

“PA-TRANSPLANTATION REFERRAL CFR(s): 494.80(a)(10) The patient’s comprehensive assessment must include, but is not limited to, the following: (10) Evaluation of suitability for a transplantation referral, based on criteria developed by the prospective transplantation center and its surgeon(s). If the patient is not suitable for transplantation referral, the basis for nonreferral must be documented in the patient’s medical record. This Standard is not met as evidenced by: 28042 Based on interview and record review the facility failed to evaluate suitability for a transplantation referral, based on criteria developed by the prospective transplantation center and its surgeon(s), and to document basis for non-referral for 1 (#6) of 6 patients reviewed, resulting in the potential for a missed opportunity for kidney transplant. Findings include: In an interview on 05/01/2024 at 0935 P-6 stated he had been doing his dialysis at home through a catheter in his stomach for over a year, but his catheter stopped working so he had to start doing his dialysis in the facility. P-6 stated he did not like doing dialysis, especially the way he has to do it now, but if he doesn’t do it, he will die. P-6 said he still works his farm and his excavating business, and will be going to work when he is done with treatment today. When asked if he had been educated about transplant, P-6 said he didn’t know anything about transplant, that nobody had every talked to him about it, but that would be great and he would love to know more about it. When asked if his Social Worker had talked to him regularly, P-6 stated he did not know who his social worker was. P-6 stated he had only been in-center for about a month, but had been doing home dialysis for over a year. P-6 was asked if he knew who his home dialysis social worker was, and he stated no. Review of P-6’s medical record on 05/01/2024 at 1300 reveled he was a 79-year-old male admitted to the facility for dialysis on 02/13/2023. Transplant assessment for P-6 completed by Social Worker Staff E on 02/23/2023 documented a check mark in a box which indicated “Patient currently in a nursing home, skilled nursing facility, on Hospice Care, or is 75 years old or older.” It indicated P-6 is not on transplant wait list. The rest of the assessment is incomplete. Provider note dated 03/29/2024 indicated P-6 was not a candidate for transplant based on age. Review of all social work notes for P-6 did not reveal any documented education or discussion of transplant, or offer to refer P-6 to transplant facility. Any and all documentation about transplant education, referral for P-6 was requested from the facility. No documentation was provided by the end of the survey. In an interview with Social Worker Staff E on 05/01/2024 at 1500, she stated in the electronic medical record each patient is assessed annually for transplant. The beginning of the assessment has a question which asks if the patient is over 75, in a nursing home, or on hospice. If the answer to any of those is yes, the box is checked and the rest of the assessment turns gray so it cannot be completed as the patient does not meet transplant criteria. When asked what the age limit is for all transplant facilities referred to by the facility, Staff E stated she did not know. When asked who made the decision if the patient is healthy enough for transplant or meets criteria, Staff E stated the transplant center. When asked if P-6 was offered a referral or referred for transplant, Staff E stated no. In an interview on 05/02/2024 at 1020, Facility Administrator Staff A stated they did not have a list of each Transplant Facility used and their transplant criteria. Staff A stated he realized by checking the “Age 75 and older” criteria box in the electronic medical record and having the system automatically exclude the patient, the facility was excluding over 40 percent of in center and home patients from being addressed for transplant. On 05/01/2024 at 0945 review of facility, Transplant Responsibilities and Guidelines” policy dated 03/02/2020, revealed, “All patients will be educated on transplant to ensure awareness of transplantation as a treatment option.” The policy also indicated, “Each dialysis clinic is required to maintain a file that lists the selection criteria for each transplant program that it refers patients to for transplant evaluation.” Documents with the criteria for transplant for each transplant facility utilized by the facility were provided to the surveyor by the facility. On 05/02/2024 at 1000 review of the documents revealed the following criteria regarding age: Facility #1: 18 years - 80 years but not exclusive criteria Facility #2: 18 years - 80 years but not exclusive criteria Facility #3: No age exclusion criteria Facility #4: Age greater than 75 years with relative co-morbidities Facility #5: Age not an absolute contraindication Facility #5: Age not an absolute contraindication, except less than 2 years of age. Facility #7: Age individualized based on co-morbid conditions Facility #8: 18 to 85 years In an interview during the exit conference on 05/02/2024 at 1245, Senior Managing Social Worker Staff M stated patients can make self referral to transplant facility if the dialysis staff determine the patient does not meet criteria.”

“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 (#2) 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 on 4/30/2024 at 1130, the hospital log for the past 6 months was reviewed and it was noted that P-2 had been hospitalized as follows: 2/23/2024-3/4/2024, 3/5/2024-3/10/2024, and 3/13/2024-3/21/2024 for gastointestinal (GI) bleeding. On 5/1/2024 at 1330, review of the plan of care list for review in April 2024 revealed P-2 was listed as unstable. Review of the medical record on 5/1/2024 at 1521 revealed the plan of care for P-2 dated 4/19/2024 indicated P-2 was stable and the next plan of care was scheduled for 4/19/2025. On 5/2/2024 at 1112, Facility Administrator Staff A stated each month the administrative assistant would make a list of the plans of care that needed to be addressed with the reason why (initial, unstable, annual, etc.) “(This list) does not mean the patient is unstable. That is determined by the IDT (interdisciplinary team). The system should have flagged this, but it didn’t. In the system, it shows the patient as being stable. They (the IDT) should have overrode the system, but they didn’t.” Staff A agreed the patient should have been made unstable due to hospitalization. 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 days 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 3 (#1, 2, 3) of 3 patients signed the plan of care on the day of the plan of care meeting resulting in the potential for the patient(s) to be uninformed and uninvolved with their care. Findings include: On 4/30/2024 at 1414, review of the initial plan of care and signature pages for P-1 dated 2/28/2024 revealed the patient did not sign the plan of care until 3/6/2024. Review of the invitation to the plan of care meeting originally set for 2/12/2024 revealed the patient wished to meet with the team chairside during physician rounds in the clinic. Additionally, the 90-day plan of care dated 4/10/2024 for P-1 did not have a patient signature until 4/15/2024. No invitation for the plan of care meeting could be found for the 4/10/2024 plan of care meeting. On 5/1/2024 at 1521, review of the annual plan of care and signature pages for P-2 dated 4/19/2024 revealed the patient did not sign the plan of care until 4/26/2024. Review of the patient invitation to the plan of care meeting revealed the patient wished to meet with the team chairside during physician rounds in the clinic. On 5/2/2024 at 1026, review of the annual plan of care and signature pages for P-3 dated 10/30/2023 revealed there was no date for the patient signature present. Review of the invitation to the plan of care meeting revealed P-3 wished to meet with the team chairside during physician rounds in the clinic. On 5/2/2024 at 0952, Facility Administrator Staff A was queried as to when the patient should be signing the plan of care to which he stated the plan of care should be signed by the patient on the day of the plan of care meeting unless otherwise designated on the signature page. He further stated the patient should be signing the plan of care at the plan of care meeting. 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.””

“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 observation, interview, and record review, the medical director failed to ensure staff followed facility policy and procedure regarding 1) removal of expired supplies, and 2) prevention of clothing from falling into a clean area during treatment initiation for 2 (#7, 8) of 5 patients observed for initiation resulting in the potential for spread of infectious agents to the 13 patients currently dialyzing on the treatment floor. Findings include: 1) On 4/30/2024 at 1035, a nearly full box of 18 gauge needles was found to have expired 8/31/2023. Additionally, several 5 ml (milliliter) syringes were found in a cup. Two expired 1/31/2021, 4 expired 5/31/2022, 1 expired 7/31/2022, and 1 was undated for expiration. These findings were confirmed by Facility Administrator Staff A at the time of discovery. On 4/30/2024 at 1041, a bottle of peach mango liquacel was found opened with no date indicating when it had been opened. Additionally, a bottle of apple liquacel was found opened with an open date of 5/10/2023. These findings were confirmed by Staff A at the time of discovery. On 4/30/2024 at 1045, review of manufacturer instructions on the liquacel bottle state, “Storage...Be sure to date when first opened. Use within 3 months of opening.” Unnumbered facility policy titled, “Storage of Supplies” published 4/5/2021 states, “Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated or damaged...All supplies must be stored and handled in accordance with manufacturer’s instructions for use...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.” 2) On 5/1/2024 at 1015, Staff K was observed in Station #10 getting P-7 ready for initiation of dialysis. P-7 was wearing a sweatshirt with a hole cut into the sleeve over her access site. Staff K began cleaning the access site; however, the edges of the cut sleeve kept falling into the cleaned area. Staff K was observed putting her gloved hands inside the sleeve and pushing it upward and outward, then pulled her hands out and picked up a needle for insertion into the access. Staff K failed to remove gloves, perform hand hygiene, reapply gloves, and re-clean the access area where the sleeve had touched. On 5/1/2024 at 1132, Staff K was observed performing exit site care for P-8’s central venous catheter (CVC). While cleaning the area with iodine, P-8’s shirt kept falling into the cleansed area around the catheter. Staff K was observed moving the shirt out of the way, but failed to remove gloves, perform hand hygiene, reapply gloves, and re-clean the access area where the shirt touched. On 5/1/2024 at 1140, Staff L was queried what should be done if clothing falls into a cleansed area that is being prepped for initiation of dialysis to which she replied that gloves should be changed and the area should be recleansed. Facility policy #45178 titled “Access Assessment and Cannulatiuon” published 7/5/2022 states, “Skin Disinfection Disinfect cannulation site...Perform skin antisepsis on one site at a time, allow to dry and them (sic) cannulate. Do not touch cannulation sites after skin disinfection.” Facility policy #45664 titled “Changing the Catheter Dressing Procedure” published 2/5/2024 was reviewed and does not address keeping patient clothing out of the way during the cleaning and dressing change process. On 5/2/2024 at 1153, Medical Director Staff N stated it was her expectation that all staff follow the policies and procedures of the facility.”