Usrc St Luke Inc. Dialysis

“Development of EP Policies and Procedures CFR(s): §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: 48296 Based on document review, observation, and interview, dialysis unit staff did not check the emergency evacuation kit per the dialysis unit’s policy and procedure. This could lead to expired supplies being available for patient care in an emergency. Findings include: -- Per review of the dialysis unit’s policy and procedure titled “Emergency Evacuation,” revised 7/2023, “emergency evacuation kits and boxes should be checked monthly for expiration dates and documented ... “ -- Per observation on 8/27/2024 at 11:00 am, the Emergency Evacuation Supply Checklist revealed the emergency evacuation kit was not checked for January 2024, June 2024, July 2024, and August 2024. Staff A, Registered Nurse confirmed the findings at the time of observation.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 32908 Based on document review and interview, 3 of 3 of the dialysis unit staff personnel files lacked an annual health assessment and tuberculosis (TB) screening to meet New York State Department of Health (NYSDOH) compliance for healthcare workers. This lack of compliance may compromise the health and safety of staff and patients. Findings include: -- Review of the dialysis unit’s policy and procedure titled “Employee Health Status Report - New Jersey and New York only,” revised 1/2021, indicated “to ensure all employees involved in direct patient care are free from communicable diseases and to promote wellness and ensure identification and follow up of infections among employees, therefore minimizing the risk of transmission to others. Physicals shall be repeated annually in New York. Each employee, including members of the medical staff, will be given a Mantoux test (a test to screen and diagnose tuberculosis) upon employment. Subsequent Mantoux testing is not required yearly but annual symptom screening and risk assessment is required.” -- Review of Staff A’s, Registered Nurse personnel file revealed they last had a pre-employment exam and TB testing on 7/26/2023. There was no documentation of an annual health assessment and TB screening for 7/2024. -- Review of Staff B’s, Licensed Practical Nurse personnel file revealed they last had a pre-employment exam on 6/12/2023 and TB testing on 5/30/2023. There was no documentation of an annual health assessment for 6/2024 and TB screening for 5/2024. -- Review of Staff C’s, Patient Care Technician personnel file revealed they last had a pre-employment exam on 6/5/2023 and TB testing (chest x-ray) on 6/5/2023. There was no documentation of an annual health assessment for 6/2024 and annual TB symptom screening and risk assessment for 6/2024. -- During interview of Staff E, Facility Administrator on 8/28/2024 at 2:15 pm, he/she/they acknowledged the above findings.”

“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: 49512 Based on document review, observation, and interview, in 9 of 9 observations, dialysis unit staff did not perform hand hygiene and use gloves as required. Dialysis unit staff also did not ensure patients performed hand hygiene post treatment before exiting the unit. Additionally, the dialysis unit’s policy and procedure lacked instruction to staff to have patients perform hand hygiene post treatment. This places patients and staff at risk for potential infection. Findings include: -- Review of the dialysis unit’s policy and procedure titled “Hand Hygiene,” revised 8/2020, indicated hand hygiene consists of either handwashing with soap and water or use of an alcohol-based formulation. Hand hygiene should be performed before and after touching a patient, prior to entering and on exiting station to provide care to patient, prior to contact with vascular access site, prior to adjusting or removing cannulation needles, before medication preparation, before clean/aseptic procedure, after body fluid exposure risk, after touching patient surroundings (e.g., dialysis machine, any items in the dialysis area or chairside computers), after gloves are removed, before and after touching personal protective equipment (PPE), after contact with inanimate objects, including medical equipment or environmental surfaces at the patient station, before entering and on exiting the patient treatment areas, when moving from a contaminated body site to a clean body site of the same patient, and after handling biohazardous waste. The policy and procedure lacked instruction to staff to have patients perform hand hygiene post treatment and/or before exiting the dialysis unit. -- Per observation on 8/27/2024 at 10:50 am, Staff D, Patient Care Technician (PCT), adjusted the dialysis machine at Station #6 while wearing gloves. Staff D did not doff gloves and perform hand hygiene before going to Station #3 to take that patient’s blood pressure. Staff D acknowledged this finding at the time of observation. -- Per observation on 8/27/2024 at 2:00 pm, Staff B, Licensed Practical Nurse (LPN), did not instruct the patient (exiting Station #1) to perform hand hygiene post fistula/graft treatment prior to exiting the dialysis unit. Staff B acknowledged this finding at the time of observation. -- Per observation on 8/27/2024 at 2:20 pm, Staff A, Registered Nurse (RN), adjusted the patients central venous catheter at Station #2, then adjusted the machine at Station #6 without changing gloves or performing hand hygiene in between. Staff A acknowledged this finding at the time of observation. -- Per observation on 8/27/2024 at 2:25 pm, Staff A, did not perform hand hygiene prior to donning gloves to perform patient care at Station #7. Staff A acknowledged this finding at the time of observation. -- Per observation on 8/27/2024 at 2:40 pm, Staff B, did not instruct the patient (exiting Station #5) to perform hand hygiene post central venous catheter treatment prior to exiting the dialysis unit. Staff B acknowledged this finding at the time of observation. -- Per observation on 8/27/2024 at 2:45 pm, Staff A, did not perform hand hygiene after removing gloves following patient care at Station #2. Staff A acknowledged this finding at the time of observation. -- Per observation on 8/28/2024 at 11:50 am, Staff A, performed central venous catheter exit site care (dressing change) at Station #4 while wearing gloves. Staff A then entered data in the dialysis machine without changing gloves or performing hand hygiene. Staff A acknowledged this finding at the time of observation. -- Per observation on 8/28/2024 at 12:00 pm, Staff A, adjusted central venous catheter connections at Station #4 while wearing gloves. Staff A then entered data in the dialysis machine without changing gloves or performing hand hygiene. Staff A acknowledged this finding at the time of observation. -- Per observation on 8/28/2024 at 12:35 pm, Staff A, entered patient data in the machine at Station #5 while wearing gloves. Staff A then went to Station #7 and entered patient data in the machine while wearing the same gloves. Staff A then responded to a patient coughing at Station #2 and entered patient data in the machine while wearing the same gloves. Gloves were not removed or hand hygiene performed between the 3 patient stations. Staff A stated he/she/they did not know that hand hygiene should be performed and gloves should be changed between patient stations. Staff A acknowledged this finding at the time of observation.”

“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: 48296 Based on document review, observation, and interview, in 1 of 1 observations, dialysis unit staff did not don proper personal protective equipment (PPE) prior to entering the dialysis station. This places patients and staff at risk for potential infection. Findings include: -- Review of the dialysis unit’s policy and procedure titled “Personal Protective Equipment (PPE),” revised 7/2023 indicated full PPE: gown, gloves and face shield or goggles with facemask is required for all staff during any procedure/activity where exposure to blood or other potentially infectious body fluids/infectious diseases is anticipated. -- Per observation on 8/27/2024 at 2:25 pm, Staff A, Registered Nurse (RN), did not don proper personal protective equipment, specifically a gown, prior to entering Station #7 to adjust the patient’s central venous catheter lines. Staff A acknowledged this finding at the time of observation.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 32908 Based on observation, document review, and interview, stock supplies of dialysis equipment were stored on a cart on the treatment floor and not in a designated clean area. This could lead to potential contamination of dialysis supplies. Findings include: -- Per observation during the flash tour on 8/27/2024 at 9:15 am, a cart housing stock dialyzers, intravenous solution, and dialysis tubing was in the treatment area and not stored in the designated clean area. -- Review of the dialysis unit’s policy and procedure titled “Infection Control Guidelines Dialysis Precautions,” revised 1/2023 indicated “clean areas should be clearly identified and separated from contaminated (dirty) areas where used supplies and equipment are handled ... If a clean cart is used to store supplies, do not take it from station to station. Keep it in a designated area at a distance from patient stations, biohazard trash and regular trash to avoid contamination. Clean areas will be clearly designated and separated from contaminated areas and unused supplies and equipment.” -- During interview of Staff E, Facility Administrator on 8/27/2024 at 9:30 am, he/she/they confirmed the above findings.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 46869 Based on observation, document review, and interview, the dialysis unit did not comply with the storage requirements for regulated medical waste under New York Codes, Rules, and Regulations (NYCRR) Title 10 Part 70. Specifically, the dialysis unit did not remove regulated medical waste rigid containers (sharps containers) from patient care areas within 30 days of start-of-use or upon reaching the fill line of the rigid container. Additionally, the dialysis unit’s regulated medical waste policy and procedure did not address New York State requirements. These findings can lead to increased risk of infection. Findings include: -- Per observation of the dialysis unit patient care area on 8/27/2024 at 9:40 am, rigid regulated medical waste containers (sharps containers) lacked the date that they were put in use. One regulated medical waste container (sharps container) had exceeded the container’s fill line and had not been removed from the patient care area. -- Review of the dialysis unit’s policy and procedure “Guidelines for the Handling and Disposal of Infectious Medical Waste,” last revised 4/2023, revealed that the policy and procedure did not address NYCRR Title 10 Part 70 requirements for the storage and disposal of regulated medical waste. -- During interview of Staff E, Facility Administrator, on 8/27/2024 at 11:15 am, he/she/they acknowledged the above findings and stated there is no system in place to date the rigid regulated medical waste containers (sharps containers) when they are put in use.”

“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: 32908 Based on document review, observation, and interview, (1) in 4 of 4 observations, dialysis unit staff did not clean and disinfect the patient scale between uses, did not clean and disinfect the surface of a chair after patient’s placed their personal items on while using the scale, and did not clean and disinfect the hand held thermometer used to scan patient’s temperatures post treatment. (2) In 1 of 1 observations, dialysis unit staff did not clean and disinfect their stethoscope used to auscultate patient’s heart and lungs between patients. (3) In 1 of 1 observations, dialysis unit staff did not clean and disinfect the dialysis machine post treatment per the dialysis unit’s policy and procedure. This places patients and staff at risk for potential exposure to infections. Findings related to (1) include: -- Review of the dialysis unit’s policy and procedure titled “Disinfection and Cleaning of Dialysis Machine Equipment,” revised 7/2023, indicated “the purpose is to provide guidance on proper disinfection of the dialysis station, machine, equipment, and surrounding surfaces with the appropriate method prevents the transmission of disease/infection to the dialysis population. Clean ancillary equipment ... “ -- Review of the dialysis unit’s policy and procedure titled “Infection Control Guidelines Dialysis Precautions,” revised 1/2023, indicated to disinfect ... electronic thermometers ... between patients ...” -- Per observation on 8/27/2024 at 10:05 am, Staff D, Patient Care Technician (PCT), did not clean and disinfect the handrail of the scale after obtaining a patient’s post treatment weight, the chair the patient used to place their personal belongings on, or the thermometer used to scan a patient’s temperature post-treatment. Additionally, cleaning/disinfecting wipes were not available in the post-treament area. Staff D confirmed the above findings at the time of observation. -- Per observation on 8/27/2024 at 10:30 am, Staff A, Registered Nurse (RN), did not clean and disinfect the handrail of the scale after obtaining a patient’s post treatment weight, the chair the patient used to place their personal belongings on, or the thermometer used to scan a patient’s temperature post-treatment. Additionally, cleaning/disinfecting wipes were not available in the post-treament area. Staff A confirmed the above findings at the time of observation. -- Per observation on 8/27/2024 at 2:40 pm, Staff B, Licensed Practical Nurse (LPN), did not clean and disinfect the handrail of the scale after obtaining a patient’s post treatment weight, the chair the patient used to place their personal belongings on, or the thermometer used to scan a patient’s temperature post-treatment. Additionally, cleaning/disinfecting wipes were not available in the post-treament area. Staff B stated these items are not cleaned and disinfected between patients and confirmed the above findings at the time of observation. -- Per observation on 8/27/2024 at 3:15 pm, Staff A, did not clean and disinfect the handrail of the scale after obtaining a patient’s post treatment weight, the chair the patient used to place their personal belongings on, or the thermometer used to scan a patient’s temperature post-treatment. Additionally, cleaning/disinfecting wipes were not available in the post-treament area. Staff A confirmed the above findings at the time of observation. -- During interview of Staff E, Facility Administrator on 8/28/2024 at 2:15 pm, he/she/they acknowledged the above findings. Findings related to (2) include: -- Review of the dialysis unit’s policy and procedure titled “Infection Control Guidelines Dialysis Precautions,” revised 1/2023, indicated to “disinfect ... stethoscopes ... between patients ...” -- Per observation on 8/27/2024 at 10:30 am, Staff A, did not clean and disinfect their stethoscope after it was used to auscultate patient’s heart and lungs. Staff A confirmed the above finding at the time of observation. Findings related to (3) include: -- Review of the dialysis unit’s policy and procedure titled “Disinfection and Cleaning of Dialysis Machine Equipment,” revised 7/2023, indicated to disinfect all surfaces of the prime waste container, inside and out, with a moistened 1:100 bleach cloth. -- Per observation on 8/27/2024 at 10:50 am, Staff D, did not clean and disinfect the internal surface of the prime waste bucket before used to prepare for another patient’s treatment. Staff D confirmed the finding at the time of observation.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 32908 Based on observation and interview the dialysis unit did not have a system for monitoring patients in the waiting room. This could lead to patient harm. Findings include: -- Per observation on 8/27/2024 at 2:00 pm, a camera was noted in the waiting room. -- Per interview of Staff E, Facility Administrator on 8/27/2024 at 2:00 pm, the camera doesn’t work and hasn’t worked for about 1 year. Staff E indicated dialysis unit staff do not monitor the waiting room. Staff E confirmed the 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: 32908 Based on observation and interview, dialysis unit staff did not provide sufficient space between a patient waiting to be placed in their dialysis chair to start treatment and stripping (removing blood lines/biohazardous waste) a dialysis machine post treatment. This could lead to possible cross contamination. Findings include: -- Per observation on 8/27/2024 at 10:15 am, Staff B, Licensed Practical Nurse (LPN) stripped a dialysis machine at Station #5 while a patient was waiting in a wheelchair pre-treatment at Station #6 (approximately 3 feet apart). The patient waiting to begin treatment should not have been in the treatment area while the dialysis machine was being stripped of biohazardous waste post treatment. -- Per interview on 8/27/2024 at 10:15 am, Staff B stated they needed to start stripping the machine to get ready for the next patient. He/she/they was unable to provide an explanation as to why the patient waiting to be placed in their dialysis chair pre-treatment was brought into the treatment area to wait while the dialysis machine was being stripped. Staff B acknowledged the above finding.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 32908 Based on observation, interview, and document review, the dialysis facility lacked posted signage in the in-center dialysis waiting room with the contact information for filing a grievance with the End Stage Renal Disease (ESRD) Network and New York State Department of Health (NYSDOH). This could lead to patients not being informed of their rights. Findings include: -- Per observation on 8/27/2024 at 9:00 am, the in-center dialysis waiting room lacked posted signage for patient rights contact information for filing a grievance with the ESRD Network and NYSDOH. Staff E, Facility Administrator, confirmed the finding at the time of observation. -- Per review of the dialysis unit’s policy and procedure titled “Patient Rights and Responsibilities,” revised 2/2023, it indicated “information to be posted includes the list of patients’ rights, the mailing address, complaint telephone numbers, and contact information for the applicable ESRD Network and the state/federal/accreditation survey agencies, as well as the U.S. (United States) Department of Health and Human Services Office for Civil Rights.””

“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: 32908 Based on document review, observation, and interview, in 1 of 2 observations, dialysis unit staff did not follow acceptable medication administration practices when patient identity was not confirmed prior to the administration of a medication. This could lead to patients receiving incorrect medication. Findings include: -- Review of the dialysis unit’s policy and procedure titled “Guidelines for Administration of Medication,” revised 4/2024, indicated “when administering a medication, the following steps will be followed: ... follow the “5 Rights” to ensure proper administration fo the medication; the right: patient, medication, dose, route of administration, time ...” -- Per observation on 8/28/2024 at 12:30 pm, Staff B, Licensed Practical Nurse (LPN), did not confirm the identity of the patient at Station #6 prior to administration of intravenous (IV) medication. Staff B acknowledged this finding at the time of observation.”