Fkc Cranberry

“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: 31759 Based on review of facility policy and procedure, and observation (OBS), and interviews with staff, the facility failed to ensure patients performed hand hygiene immediately after glove removal for two (2) of two (2) observations of discontinuation of dialysis with an arteriovenous fistula (AVF) (OBS#5.1, & OBS#5.2). Findings included: Review of facility policy and procedure on April 3, 2025, at 12:30 p.m. showed, “Post Treatment Needle Removal ... Procedure ... Step 2. If the patient will be holding pressure on the [needle] site, assist patient in gloving hand to reduce blood contamination. ... 12. Remove and discard gloves. Perform hand hygiene per policy. Instruct patient holding the sites to perform hand hygiene.” Review of facility policy and procedure on April 3, 2025, at 12:35 p.m. showed, “Hand Hygiene ... The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. All staff, patients, ... 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 ... When ... Immediately [EMPHASIS] after removing gloves.” Observation (OBS#5.1) of discontinuation of dialysis with an AVF on April 2, 2025, at 1:05 p.m. at station 5 revealed EMP6 remove needles from patient’s arm, and cover sites with gauze dressing. The patient held pressure to gauze dressings with a gloved right hand in order to stop bleeding. Once bleeding had stopped, the patient removed glove, and without performing hand hygiene left the station and proceeded to touch facility’s scale with their hands. Interview with EMP1 (clinic manager) at 1:06 p.m. confirmed findings. Observation (OBS#5.2) of discontinuation of dialysis with an AVF on April 2, 2025, at 1:42 p.m. at station 7 revealed EMP8 remove needles from patient’s arm, and cover sites with gauze dressings. The patient then held pressure to the gauze dressing with a gloved left hand in order to stop bleeding. Once bleeding had stopped, the patient removed the glove, and without performing hand hygiene left the station. Facility staff requested patient to sanitize hands before leaving the facility and he/she replied, “I’ll wash my hands when I go to the [facility’s] bathroom.” EMP1, who was present during the observation, confirmed findings at 1:43 p.m.”

“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: 31759 Based on review of facility policy, observations, and staff (EMP) interview, the facility failed to ensure one (1) of two (2) employees (EMP8) wore appropriate personal protective equipment (PPE). Findings included: Review of facility policy on April 3, 2025, at 12:30 p.m. showed, “Personal Protective Equipment ... Occupational Exposure - Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infections materials that may result from the performance of an employee’s duties. ...Personal protective equipment including a full-face shield or mask and protective eyewear with full side shield, ... must be worn to protect employees from blood or other potentially infectious materials (OPIM).” Observation of discontinuation of dialysis with arteriovenous fistula (AVF) on April 2, 2025, at 12:55 p.m. at station 7 revealed EMP8 remove needles from patient’s arm. EMP8 work a mask and goggles but EMP8’s mask did not cover his/her nose (mucous membrane). Interview with EMP8, and EMP1 (clinic manager) present, on April 2, 2025, at 1 p.m. confirmed findings. At 1:45 p.m., after EMP8 was alerted to his/her mask not covering his/her nose, he/she was observed at station 2 removing needles from patient’s AVF with gloved hands. At this time, EMP8’s mask did not cover his/her nose, and he/she repeatedly used his/her gloved hands to move mask back up because it would not stay in place over his/her nose.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 31759 Based on review of facility policy, facility QAPI (quality assurance performance improvement) program, hospitalization logs, a clinical record, and staff (EMP) interview, the facility failed to record and follow up on all patient infections in order to analyze and document the incidence of infections to identify trends and establish baseline information on infection incidence; develop recommendations and action plans to minimize infection transmission, promote immunization; and take actions to reduce future incidents for one (1) of one (1) patient with a covid-19 infection (CR5). Findings included: Review of facility policy on April 3, 2025, at 12:40 p.m. showed, “Quality Assessment and Performance Improvement Program [QAPI] ... QAPI requires the use of aggregate patient data to evaluate the facility patient outcomes. ... The QAPI Committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care. ... Elements to be reviewed include: ... Infection Surveillance.” Review of “Absence and Hospitalization ... Report From Date: 4/1/2024” on April 2, 2025, at 10:30 a.m. showed CR5 was hospitalized for “Covid-19 - Acute Respiratory Failure” on 10/7/2024. Review of CR5 on April 2, 2025, at approximately 11 a.m. showed a hospital discharge summary from 10/8/2024, “[Hospital] Discharge Clinical Summary ... Discharge Diagnosis COVID-19.” Review of CR5’s treatment sheets showed the patient dialyzed at the facility on 10/4/2024, and again on 10/9/2024. Review of facility’s QAPI infection tracking logs for the above time frame (October 2024), on April 2, 2025, at 11 a.m., confirmed CR5’s covid-19 infection was not documented in the log. Interview with EMP1 (clinic manager) at time of review confirmed findings and that CR5’s covid-19 infection was not logged for review in QAPI.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 31759 Based on review of facility policy, observation, manufacturer directions for use, and staff (EMP) interview, the facility failed to ensure two (2) of two (2) registered nurses disinfected items taken into the dialysis station (EMP1, & EMP3). Findings included: Review of facility policy on February 26, 2024, at 11:35 a.m. showed, “Cleaning and Disinfecting the Dialysis Station ... The purpose of this policy is to provide guidelines to prevent the spread of infectious disease ... After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station.” Observation of EMP3 on February 26, 2024, at 10:50 a.m. revealed him/her assess a patient at station 7. Once finished with the assessment, EMP3 hung his/her stethoscope around his/her neck and left the station. EMP3 walked to clean supply area and wiped his/her stethoscope with a small 4.5cm x 9cm (centimeter) alcohol (70% isopropyl) pad and hung it on the wall with other stethoscopes. Observation of EMP1 on February 26, 2024, at 10:56 a.m. revealed him/her assess a patient at station 3 while patient was dialyzing. Once finished with the assessment, EMP1 left the station with his/her stethoscope. EMP1 walked to clean supply area and wiped his/her stethoscope with a small 4.5cm x 9cm alcohol pad and hung it on the wall with other stethoscopes. Interviews with EMP1 and EMP3, and review of the alcohol wipe wrapper and its directions for use on February 26, 2024, at 11 a.m. confirmed findings. Per the directions for use, “ALCOHOL PREP PAD ... Directions ... apply topically as need to cleanse intended area.” Interview with EMP4 (administrator) on February 26, 2024, at 12:05 p.m. confirmed the alcohol prep pad used by EMP1 and EMP3 was not bleach or an EPA registered disinfectant as outlined in facility policy.”

“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: 31759 Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure clean areas were separated from contaminated areas, and that unused supplies and patient care items were stored in a clean area. Findings included: Review of facility policy on February 26, 2024, at 12:05 p.m. showed, “General Cleanliness and Infection Control Guidelines Purpose The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, aesthetically pleasant environment for patients, staffs, and visitors. ... 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.” Review of facility policy on February 27, 2024, at 11 a.m. showed, “Storage of Supplies ... 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 in a clean ... environment.” Observation on February 26, 2024, at 9:30 a.m. revealed the facility stored a large pallet of supplies, and two (2) wheelchairs in the corridor leading into the patient treatment area. Observation on February 26, 2024, at 9:35 a.m. revealed the facility was storing an unused 55-gallon drum of acid (intended to be clean and used in water room to make dialysate) in the patient’s bathroom (not a clean area). Observation on the treatment floor on February 26, 2024, at 9:45 a.m. revealed that the “biohazard” sharps container (used to store used needles etc.) attached to the hemodialysis machine at station 4, while a patient was dialyzing, was situated adjacent to the facility’s medication storage fridge. Observation of the staff bathroom on February 26, 2024, at 12 p.m. revealed it contained an unused 55-gallon drum of acid, and patient care items such as a Hoyer lift (used in treatment area to transfer patients from their wheelchairs to their treatment chairs), and a patient privacy partition. The cord for charging the Hoyer lift was fashioned over the sink and plugged into the wall. Interviews with EMP1 (clinic manager) and EMP4 (administrator) on February 26, 2024, at 12 p.m. confirmed above findings.”

“PE-PT CARE ENVIRONMENT-SUFFICIENT SPACE CFR(s): 494.60(c)(1) The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. This Standard is not met as evidenced by: 31759 Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure sufficient space was available to provide care and services in a manner that allowed for emergency exit corridors to remain clear; that allowed clean items to be stored in a clean area; and that allowed a contaminated item to be separated from clean supplies. Findings included: Review of facility policy on February 26, 2024, at 12:05 p.m. showed, “General Cleanliness and Infection Control Guidelines ... The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, aesthetically pleasant environment for patients, staffs, and visitors. ... 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.” Review of facility policy on February 27, 2024, at 11 a.m. showed, “Storage of Supplies ... 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 in a clean ... environment.” Observation of corridor leading into the facility on February 26, 2024, at 9:30 a.m. revealed a large pallet full of supplies on one side of the corridor. The facility also stored two (2) wheelchairs in this corridor due to limited space inside the clinic. This arrangement reduced the corridor width to 24 inches (not large enough for a wheelchair or stretcher to pass). Observation on February 26, 2024, at 9:35 a.m. revealed the facility was storing an unused 55-gallon drum of acid (intended to be clean and used in water room to make dialysate) in the patient’s bathroom (not a clean area). Observation on the treatment floor on February 26, 2024, at 9:45 a.m. revealed that the “biohazard” sharps container (used to store used needles etc.) attached to the hemodialysis machine at station 4, while a patient was dialyzing, was situated adjacent to the facility’s medication storage fridge so that it was slightly in front of the fridge’s front facing panel. Observation of the staff bathroom on February 26, 2024, at 12 p.m. revealed it contained an unused 55-gallon drum of acid, and patient care items such as a Hoyer lift (used in treatment area to transfer patients from their wheelchairs to their treatment chairs), and a patient privacy partition. The cord for charging the Hoyer lift was fashioned over the sink and plugged into the wall. In order to was hands in the sink, staff would have to unplug the cord or duck underneath it (the cord has some elasticity). Interviews with EMP1 (clinic manager) and EMP4 (administrator) on February 26, 2024, at 12 p.m. confirmed above findings.”

“PE-INCORPORATION BY REFERENCE CFR(s): (f) Incorporation by reference. The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain the material from the sources listed below. You may inspect a copy at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@nara.gov, or go to: www.archives.gov/federal__register/cfr/ibr-locations.html. If any changes in the editions of the Codes are incorporated by reference, CMS will publish a document in the Federal Register to announce the changes. (1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org, 1-617-770-3000. (i) NFPA 99, Health Care Facilities Code, 2012 edition, issued August 11 2011. (ii) TIA 12-2 to NFPA 99, issued August 11, 2011. (iii) TIA 12-3 to NFPA 99, issued August 9, 2012. (iv) TIA 12-4 to NFPA 99, issued March 7, 2013. (v) TIA 12-5 to NFPA 99, issued August 1, 2013. (vi) TIA 12-6 to NFPA 99, issued March 3, 2014. (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011. (viii) TIA 12-1 to NFPA 101, issued August 11, 2011. (ix) TIA 12-2 to NFPA 101, issued October 30, 2012. (x) TIA 12-3 to NFPA 101, issued October 22, 2013. (xi) TIA 12-4 to NFPA 101, issued October 22, 2013. (2) [Reserved] This Standard is not met as evidenced by: 31759 Based on review of 2012 NFPA (National Fire Protection Agency) 101 standards, observation, posted facility evacuation route, and staff (EMP) interview, the facility failed to ensure one of two exit routes were kept clear (EXIT1). Findings included: Review of 2012 NFPA 101 on February 27, 2024, at 9 a.m. showed, “Chapter 19 Existing Health Care Occupancies ... 19.1 General Requirements ... 19.2.3.5 The aisle, corridor, or ramp shall be arranged to avoid any obstructions to the convenient removal of nonambulatory persons carried on stretchers or on mattresses serving as stretchers.” Observation of corridor leading into the facility (EXIT1) revealed a large pallet full of supplies on one side of the corridor and two (2) wheelchairs located on the other side of the corridor. This arrangement reduced the corridor’s width to 24 inches. Interview with EMP1 (clinic manager) on February 26, 2024, at 10 a.m. confirmed findings.”