Fmc - Lexington Park Dialysis

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 44367 Based on the overall findings of the survey, it was determined that the facility’s Medical Director failed to provide an effective oversight of the patient care delivery and the staff’s compliance with the regulatory requirements and facility’s policies. This was evidenced by wide-spread non-compliance of the facility’s staff with the facility’s own policies and procedures and manufacturer’s instructions on assembly of dialysis machines and performance of safety checks prior to initiation of dialysis treatment. This failure placed the facility patients at potential risk of serious injury, serious harm and possible death. The findings include: 1) Responsibilities of the Medical Director - Ensure All Adhere to Policy and Procedure (V0715)”

“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: 44367 Based on inspection of the emergency evacuation box and binder, the facility’s administrative staff failed to maintain a current list of all of the facility patients for the purpose of tracking in the event of an emergency evacuation. The failure to provide an updated patient list could potentially result in a patient’s injury or harm in the event of an evacuation. Patients: #7, #8, #9, #10, #11 and #12 Findings include: On 08/01/2024, surveyor reviewed the facility’s policy entitled “Emergency Medication, Equipment and Supplies,” which stated on page 2, “An emergency box must: Contain all patient and staff emergency contact information.” On 08/01/2024 at 11:30 a.m., inspection of the facility’s emergency evacuation kit revealed that six (6) out of the fifty-eight (58) patients were found not be included in the facility’s patient contact list. The patient list was last updated on 05/22/2024. The Clinical Manager was informed of the findings on 08/01/2024.”

“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: 44367 Based on observations, staff interviews and record review, the facility’s administration and the Medical Director failed to confirm that emergency equipment was available and in proper working condition; supplies and medication were secure and non-expired. This failure placed the safety and well-being of the patients at potential risk of harm in the event of an emergency evacuation. Findings included: Review on 08/01/2024 of the facility’s policy entitled “Emergency Medication, Equipment and Supplies” revealed that page 2 stated: “The emergency cart must be: checked monthly or after use for contents, expiration dates, cleanliness and proper functioning of all equipment. On 08/01/2024 at 10:54 a.m., during inspection of the facility’s patient restrooms, surveyor determined that the alarm system did not work. Surveyor pulled the emergency cord in the restroom located in the unit, the alarm did not sound and the light over the door did not come on. The Clinical Manager corroborated that the alarm did not work. On 08/01/2024 at 11:30 a.m., inspection of the facility’s crash cart revealed six (6) vials of Diphenhydramine 50 mg/ml, lot number DBTU0087, expired 7/24/2024 . Review on 08/01/2024 of the facility’s policy entitled “Use of Cardiac Science - Powerheart Automated External Defibrillator (AED)” determined that page 1 stated, “A daily inspection log must be maintained verifying status indicator is GREEN indicating the Powerheart AED is ready for use.” Review on 08/01/2024 of the facility’s AED log revealed that the AED was not inspected on the following days: · 07/16/2024, · 06/29/2024 · 05/09/2024, 05/17/2024 and 05/31/2024 · 04/03/2024 and 04/11/2024 The Clinical Manager and the Charge Nurse were informed of the findings on 08/01/2024.”

“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: 44367 Based on clinical observations and review of facility policy, it was determined that the facility’s administration failed to ensure that the standards of care related to hand hygiene and glove use requirements were followed by all staff who come in contact with the dialysis patients in the facility. This failure placed the patients and staff at potential risk for nosocomial infections (infections acquired while in a healthcare setting). Staff: #3 and #6 Findings included: According to the Centers for Disease Control and Prevention (CDC), infection can be spread in a dialysis center through the passing of microorganisms from one patient to another by the hands of the caregiver; or if the environmental surfaces are contaminated and touched by a caregiver or patient. Even with glove use, hand hygiene is necessary before gloves are put on and after gloves are removed because hands can become contaminated through small defects in gloves and from the outer surface of the gloves during glove removal. On 07/30/2024, surveyor’s review of page 2 of the facility’s policy entitled “Personal Protective Equipment” revealed the following excerpt, “Change gloves and practice hand hygiene between each patient and/or station to prevent cross contamination.” During surveyor’s observations of the clinical treatment area on 07/30/2024 at 11:09 a.m., Staff #3 was performing treatment termination of the patient at station #1. Staff #3 walked from station #1 to the nurses station across from station #4 to press the bicarbonate alarm button without removing gloves and performing hand hygiene. Staff #3 then went back to the patient at Station #1 to continue the termination process with the same gloves. During surveyor’s observations of the clinical treatment area on 08/01/2024 at 11:09 a.m., Staff #6 removed glove during treatment initiation of the patient at station #8 and did not conduct hand hygiene before getting clean supplies from the counter across from station #8. The Clinical Manager was informed of the findings on 07/30/2024 and 08/01/2024.”

“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: 44367 Based on observations of care and review of the facility’s policies, the governing body failed to ensure that personal protective equipment (PPE) was worn in the treatment area where there was potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces. This failure posed a risk of exposure to infectious diseases and blood borne pathogens to other staff members, as well as patients. Staff: #3 and #4 Findings included: Personal protective equipment (PPE) is defined by the Occupational Safety and Health Administration (OSHA) as “specialized clothing or equipment, worn by an employee for protection against infectious materials.” On 07/31/2024, surveyor reviewed the facility’s policy entitled “Personal Protective Equipment.” Page 1 of the policy stated, “Personal protective equipment including a full-face-shield or mask and protective eyewear with full side shield, fluid-resistant gowns, and gloves, must be worn to protect employees from blood or other potentially infectious materials (OPIM). PPE is used to protect employees who are occupationally exposed to blood or OPIM when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination, cleaning of dialyzer, and centrifugation of blood).” 1. During surveyor’s observations of the clinical treatment area on 07/31/2024 at 10:05 a.m., Staff #3 did not have on protective eyewear or a face shield during treatment termination of the patient at station #1. 2. During surveyor’s observations of the clinical treatment area on 08/01/2024 at 10:49 a.m., Staff #4 did not have on any PPE while speaking with the patient during the treatment termination process at station #10. The Clinical Manager was informed of the findings on 07/31/2024 and 08/01/2024.”

“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: 44367 Based on observations of the clinical treatment area, the Clinical Nurse Manager and Medical Director failed to ensure that the clinical staff followed safe practices when handling infectious wastes. This failure created a potential risk of blood exposure and risk of harm to patients and staff in the unit. Staff: #1 Findings included: The Occupational Health and Safety Administration (OSHA) regulation at 29 CFR 1910.1030(d)(2)(xi) states: All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. Carrying contaminated blood tubing, used needles, syringes and dialyzer from the patient’s station across the treatment floor to a biohazard box, or sharps container could result in unknown spattering of blood. During surveyor’s observation of the clinical treatment area on 08/01/2024 at 11:54 a.m., Staff #1 walked dirty bloodlines from station #12 across occupied station #13 to discard in the biohazard trash bin. The Clinical Manager was informed of the findings on 08/01/2024.”

“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: 44367 Based on clinical observations and review of facility policies, the governing body failed to ensure that the clinical staff followed the standard regulations in the cleaning and disinfection of contaminated equipment used in the facility. This failure put patients at risk for possible cross-contamination. Findings included: Review on 07/30/2024 of the facility’s policy entitled “Prime Bucket Disinfection” determined that page 1 stated, “Dispose of saline solution down any marked dirty sink...Clean all surfaces of the prime bucket or approved receptacle, with 1:100 bleach solution or an approval 1:100 bleach disinfect wipe.” Surveyor’s observation on the clinical treatment area on 07/30/2024 revealed the following: At 10:18 a.m., Staff #6 did not clean the prime bucket during the machine disinfection process at station #1. At 10:36 a.m., Staff #6 did not clean the prime bucket during the machine disinfection process at station #2. On 07/30/2024, review of the facility’s policy titled “Cleaning and Disinfection of the Dialysis Station” revealed that: “Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately is splattered with blood.” On 07/30/2024 at 10:46 a.m., Staff #6 disinfected the dialysis machine at station #1 and closed the station for the day. Staff #6 did not clean the wall box. On 07/30/2024 at 10:00 a.m., the surveyor noted a white build up on the surface and the red and blue ports at stations #1, 2, 14,15, 16 and the isolation room. The Clinical Manager was informed of the findings on 07/30/2024.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 44367 Based on personnel record review, the Facility’s Administration and the Medical Director failed to ensure that facility staff members received the education and training on infection control practices for hemodialysis as required. This failure placed patients, visitors and staff at potential risk for exposure to bloodborne pathogens and infectious diseases. Staff: #1 and #3 Findings include: According to the Occupational Safety and Health Administration (OSHA), dialysis staff must receive bloodborne pathogen training annually with personnel records reflecting staff having received appropriate infection control training. Furthermore, the Centers for Disease Control and Prevention (CDC) also states that they recommend infection control training initially on employment and annually. On 07/31/2024, during record review of the facility’s “ESRD Personnel File Review” form, the surveyor noted that 2 out 10 employees did not complete their annual infection control training. The Clinical Manager was given the opportunity to provide additional information; however, no additional information was provided. Staff #1’s last annual Infection control training was completed on 08/18/2021. Staff #3’s last annual infection control training was completed on 06/28/2023. The Clinical Manager agreed with the findings on 07/31/2024”

“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: 44367 Based on clinical observations and interviews with the administrative staff, the facility’s governing body and the Medical Director failed to ensure that expired medications were removed from the available medication supply. This failure placed the patients at potential risk of harm of receiving expired medication. Findings include: Review on 08/02/2024 of the facility’s policy entitled “Medication Preparation and Administration” revealed that “Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded via fresenius Kidney Care off-site return program or in accordance with local and/or state law...CDC immunizations program states vaccines are to be discarded per manufacturers expiration date.” Inspection of the facility’s medication area on 08/02/2024 revealed that fifty-four (54) 100 ml bags of 0.9% Sodium Chloride, lot number U5013659, expired on 05/2024.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the governing body and the medical director failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #1 and #6 Findings include: According to the National Institute of Health (NIH), “A central venous catheter (CVC) is an indwelling device inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium [parts of the heart].” Review of the facility’s policy entitled “Changing the Catheter Dressing Procedure” determined that page 2 stated, “2% Chlorhexidine and 70% alcohol: Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds.” Page 4 states, “Inspect and remove old dressing...Discard dressing and remove gloves. Perform hand hygiene. Prepare dressing supplies...Perform hand hygiene and don gloves...” Review of the facility’s policy “Initiation of Treatment Using a Central venous Catheter and Optiflux Single Use Ebeam Dialyzer” determined that page 4 stated, “Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) for 10-15 seconds and any time caps are removed, or bloodlines are disconnected (i.e. end of treatment or treatment interruption) to reduce risk of contamination.” Observation of the clinical treatment area on 08/01/2024 at 06:12 a.m. revealed that, during initiation of treatment at station 13, Staff #1 cleaned catheter exit site for twelve (12) seconds. Staff #1 scrubbed the arterial hub for 3 seconds and the venous hub for 8 seconds. Observation of the clinical treatment area on 08/01/2024 at 06:16 a.m. revealed that, during initiation of treatment at station 6, Staff #6 scrubbed the venous hub for 9 seconds and the arterial hub for 8 seconds. Staff #6 cleaned the catheter exit site for 9 seconds and allowed to dry for only 15 seconds before placing a new dressing. Staff #6 did not change gloves and perform hand hygiene during the dressings change process. Observation of the clinical treatment area on 08/01/2024 at 06:36 a.m. revealed that, during initiation of treatment at station 9, Staff #6 cleaned the catheter exit site for 10 seconds and did not allow to dry time before placing a new dressing. Staff #6 scrubbed the venous hub for 7 seconds and the arterial hub for 8 seconds. Staff #6 did not change gloves and perform hand hygiene during the dressings change process. Observation of the clinical treatment area on 08/01/2024 at 06:59 a.m. revealed that, during treatment initiation of treatment at station #11, Staff #1 clean the catheter exit site for 19 seconds. Staff #1 allow the site to dry for only 15 seconds prior to placing the new dressing. The Clinical Manager and the Educator were informed of the findings on 08/01/2024.”

“BACT OF H20-MEDICAL DIRECTOR RESPONSIBLE CFR(s): 494.40(a) 4.1.2 Bacteriology of water: med dir resp The facility medical director is responsible to ensure the manufacturer or supplier of a complete water treatment and distribution system demonstrates that the complete water treatment, storage, and distribution system is capable of meeting these requirements at the time of installation Following installation of a water treatment, storage, and distribution system, the user is responsible for continued monitoring of the water bacteriology of the system and for complying with the requirements of this standard, including those requirements related to action levels. This Standard is not met as evidenced by: 44367 Based on review of the Reverse Osmosis (RO) water, dialysate and Hemodialysis (HD) machine culture logs and interviews with the biomedical technician, the governing body and medical director failed to ensure that systems were continually monitored for bacteria colony forming units and endotoxins. This failure to provide oversight for the RO water, dialysate, and HD machine cultures placed the facility’s patients at risk of harm and potential exposure to infection. Findings included: On 07/30/2024, surveyor review of page 5 of the facility’s policy, “AAMI Chemical Analysis of Water and Dialysis” identified the following excerpt, “Medical Director must review and sign each chemical analysis report obtained during the review period.” Review on 07/30/2024 of the facility’s monthly RO water, dialysate, HD machine culture reports, and an interview with the Biomedical staff and the Clinical Manager revealed the medical director did not sign and date (proof of acknowledging the culture collection results during the review period) reports for January 2024, February 2024, March 2024, April 2024 and June 2024. The Biomedical Technician and the Clinical Manager corroborated the findings on 07/30/2024. The Biomedical Technician and the Clinical Manager were informed of the findings on 07/30/2024.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 44367 Based on observations of the facility’s bicarbonate tank and a review of the facility’s policies and procedure, the facility’s administration and the medical director failed to ensure that the bicarbonate tank’s content was labeled correctly. This failure placed the patients at potential risk for harm. Findings include: On 07/30/2024, review of page 2 of the facility’s policy entitled “Concentrate Labeling requirements,” revealed, “Mix tank labeling must include: Contents identification. For example, “Bicarb”, “Acid”, “RO Water” or Disinfectant”...Date time of mixing.” On 07/30/2024 at 9:00 a.m., during a flash tour of the facility’s water treatment room, surveyor noted that the tank labeled “Bicarb Distribution Tank” had 70 gallons of clear liquid, but the tank did not have a date, time, or initials. The Clinical Manager and the Biomedical Technician were informed and observed the findings on 07/30/2024.”

“BICARB MIX SYS-STOR/USE TIME/MIN COMBINE CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: storage/use time limits/min combine Once mixed, bicarbonate concentrate should be used within the time specified by the manufacturer of the concentrate. 7 Strategies for bacterial control 7.1 General Storage times for bicarbonate concentrate should be minimized, as well as the mixing of fresh bicarbonate concentrate with unused portions of concentrate from a previous batch. The manufacturer’s instructions should be followed if they are available. This Standard is not met as evidenced by: 44367 Based on observations of the facility’s bicarbonate tank and a review of the facility’s policies and procedures, the facility’s administration and the medical director failed to ensure that the bicarbonate was used within the time frame recommended by the manufacturer. This failure placed the patients at potential risk for harm. Findings include: Review on 08/02/2024 of the facility’s policy entitled “Bicarbonate Concentrate Mixing” page 4 stated, “Bicarbonate concentrate solution expires 24 hours after mixing and must be used or discarded within this time period.” On 08/02/2024 at 05:46 p.m., observation of the facility’s water treatment room revealed that the tank labeled “Bicarb Distribution Tank” had 80 gallons of clear liquid. The tank had a labeled that stated, “7/30/2024 5:30 a.m. LS.” The Team Leader and the Clinical Manager observed and agreed with the findings on 08/02/2024.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 44367 Based on observations of the environment of care, it was determined that the facility failed to maintain a safe and functional environment of care, as evidenced by presence of multiple expired supplies throughout the facility. Findings include: Observation of the clinical treatment area and the supply room on 07/30//2024 through 08/01/2024 revealed the following expired supplies: a) Fifty (50) 14 gauge Biohole Fistula Needles, lot number 19C10, expired 02/28/2024. b) Twenty (20) boxes of Surgical Face Mask, lot number 210115, expired 01/14/2024. c) Fourteen (14) Disposable Monofilament, lot number NG120GS, expired 01/22/2023. d) One (1) bottle of Ozone in Water Strips, lot number 5229B2, expired 03/31/2024. e) Twelve (12) bottles of Residual Chlorine strips, lot number UJ375021, expired 04/2024.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 44367 Based on observations of care, review of patient record, facility policy and manufacturer’s instructions, and interviews with staff, the facility’s governing body failed to ensure that the facility staff operated dialysis equipment in accordance with manufacturer’s instructions. This was evident when: 1) staff failed to ensure the air detector was armed while patients are receiving treatment; and 2) staff failed to perform safety testing of a dialysis machine in accordance with the manufacturer’s instructions. This failure placed the affected facility patients at risk for harm and/or death. Findings include: 1) On 07/31/2024 at 2:30 p.m., during review of the facility’s policy “Pre-Treatment Safety Checks Procedure” page 3 states, “The clinician initiating treatment must visually check the extracorporeal circuit prior to patient being connected after the machine has been primed and recirculated to ensure: The air detector is armed, and the venous drip chamber bloodline is threaded through the occlusion clamp.” Review on 07/31/2024 of the facility’s policy entitled “Patient Assessment and Monitoring” page 6 stated, “Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes or per state regulations. Follow the steps below for monitoring patient and machine parameters during treatment: Observe and ensure that: Tubing is correctly threaded and clamped in the air detector.” On 07/31/2024 at 2:17 p.m., during observations of the treatment floor, the surveyor observed that the air detector on machine #4 located at station #5 was unarmed while Patient #1 was receiving treatment. At 2:17 p.m., Staff #1 corroborated that the air detector was unarmed. Staff #1 armed the air detector after the surveyor brought the finding to their attention. At 2:18 p.m., the Clinical Manager (CM) was informed of the findings and the safety issue. The Clinical Manager instructed the Staff to stop Patient #1’s treatment after the surveyor brought the finding to their attention. Subsequent review on 07/31/2024 of Patient #14’s flowsheet revealed that the treatment was initiated at 12:30 p.m.. Patient #14 had three (3)documented safety checks completed at 01:00 p.m., 01:32 p.m., and 02:02 p.m. The “Machine setup” section of the flowsheet revealed that the section “air detector armed” was verified by Staff #8 and Staff #10, prior to treatment initiation. Despite all documented safety checks, Patient #14 machine’s air detector was found unarmed. The facility’s practice of providing dialsysis treatment to a patient while elements of the machine were not assembled according to manufacturer instructions placed the affected patients at risk of serious injury, serious harm, and possible death. Due to the seriousness of the concern that the facility staff failed to operate dialysis machines according to manufacturer’s recommendations, an Immediate Jeopardy (IJ) statement #1 was issued at 4.35 p.m. on 07/31/2024 by the Office of Health Care Quality (OHCQ). On 08/02/2024 at 5.00 pm, surveyor confirmed that the Immediate Jeopardy finding was removed after an onsite verification that the facility fully implemented corrective steps identified in the acceptable IJ removal plan. The steps taken by the facility to remove the IJ can be summarized as follow: a) Facility immediately provided training to staff with emphasis placed on ensuring that staff visually checked the extracorporeal circuit prior to the patient being connected after the machine was primed and recirculated and ensuring that the air detector was armed, and the venous drip chamber bloodline was threaded through the occlusion clamp. b) Facility implemented an ongoing audit procedure on 08/01/24 for every machine to be inspected prior to treatment initiation by an RN (not assigned to patient care) to ensure the venous line was in the occluding clamp and the venous air detector was armed per policy. RN to address any variation from the policy and report results of audits to Clinical Manager. c) Clinical Manager to be responsible for progressive discipline in cases of non-compliance with policies and to share audit results with clinic staff twice a day beginning on 08/01/24. d) Governing Body began meeting daily on 08/01/24 to review the removal plan progress and audit results until compliance is sustained at 100% x 2 weeks. 2) On 08/02/2024 at 6:10 a.m., during review of the Fresenius 2008T Machine Operator ’ s Manual, page 74 stated: “Warning! ...If the machine fails this or any of the pressure, alarm, and diasafe tests and the cause cannot be corrected, or if it fails subsequent tests, do not use it for treatment. Remove the machine from service and have it inspected by a qualified technician to correct the problem.” On 08/02/2024 at 6:06 a.m. the surveyor observed that machine #15 located at station #16 failed the safety tests two consecutive times. The surveyor observed the Clinical Manager (CM) instruct Staff #1 to retest for a third time. At 6:07 a.m., the Staff #1 conducted a 3rd safety test on machine #15. The patient was waiting in the lobby to receive treatment. At 6:08 a.m., the CM was informed of the findings and the safety issue. The CM stated that because only one test was conducted the second time that both tests could be conducted a third time. The CM instructed Staff #1 to pull machine #15 after the surveyor brought the finding to their attention. Due to the seriousness of the concern that the facility staff failed to operate dialysis machines according to manufacturer’s recommendations, by passing alarms and using equipment after failed safety checks, an immediate jeopardy (IJ) statement #2 was issued at 10.45 am on 08/02/2024 by the Office of Health Care Quality (OHCQ). On 08/02/2024 at 5.00 pm, surveyor confirmed that the Immediate Jeopardy finding was removed after an onsite verification that the facility fully implemented corrective steps identified in the acceptable IJ removal plan. The steps taken by the facility to remove the IJ can be summarized as follow: a) Facility immediately provided training to staff, including Clinical Manager, with emphasis placed on the requirement to remove the machine from service if it fails testing x 2 to be inspected and repaired by BioMed and allowing machine to test automatically following set up. b) Facility implemented an ongoing audit procedure on 08/02/24 for the Clinical Manager or an RN designee to ensure that every machine passed testing within 2 attempts, or the machine would be immediately removed from service to be inspected and receive required repairs/adjustments by Biomedical staff. c) Clinical Manager to be responsible to share audit results with clinic staff beginning on 08/02/24. d) Governing Body began meeting daily on 08/02/24 to review the removal plan progress and audit results until compliance is sustained at 100% x 2 weeks. Governing Body to monitor machine failure status and develop a plan to divert patients to sister clinics for treatments if there are multiple machines not passing the pretreatment safety tests, as needed.”

“PR-CAN HAVE ADVANCE DIR,TOLD FAC AD P&P CFR(s): 494.70(a)(6) The patient has the right to- (6) Be informed about his or her right to execute advance directives, and the facility ’ s policy regarding advance directives; This Standard is not met as evidenced by: 44367 Based on medical record review, the facility administrator and medical director failed to ensure that all of the facility’s patients were given information about creating an advance directive on admission. This failure denied the patients their rights to formulate treatment decisions that served their end of life needs. Patients: #3 and #4 Findings included: On 07/30/2024, review of page 1 of the facility’s policy entitled “Advance Directive” revealed, “All new patients will be asked if they have a current Advance Directive (otherwise known as a “Living Will”) designating a health care agent and/or specifying the medical care they wish to receive or not receive...If the patient does not currently have an Advance Directive, they will be asked if they would like information regarding end-of-life options and Advance Directives.” A review of the medical records on 07/30/2024 revealed that two (2) out of five (5) of the selected patients were not provided information or given the option to create an advanced directive. The findings were as follows: Patient #3 was admitted to the facility on 09/02/2022. No advance directive or advance directive acknowledgement form was found in the patient’s paper or electronic chart. Patient #4 was admitted to the facility on 10/18/2021. No advance directive or advance directive acknowledgement form was found in the patient’s paper or electronic chart. The Clinical Manager was informed of the findings on 07/30/2024.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 44367 Based on review of medical records and interviews with the facility’s administrative staff, the governing body failed to ensure that a registered nurse (RN) completed an initial nursing assessment prior to the patients’ initial dialysis treatment when being admitted to the facility for 1 of 5 patients reviewed ( Patient #3). Findings included: On 07/30/2024, review of the facility’s policy entitled “Comprehensive Interdisciplinary Assessment and Plan of Care” revealed that: “A registered nurse must perform an assessment on patients new to dialysis before initiation of their first treatment to determine immediate needs.” During a review of five (5) selected patients’ medical records on 07/30/2024, the surveyor noted that one (1) out of the five (5) or 20% of the selected patients’ paper or electronic charts did not contain an initial nursing assessment. The assessment should have been completed prior to the patient being placed on the dialysis machine on the day of admission. The Clinical Manager was given the opportunity to provide the missing initial nursing assessments; however, the Clinical Manager corroborated that the initial nursing assessment was not completed.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 44367 Based on review of the dialysis patients’ treatment flowsheets, the facility’s administration and clinical staff failed to ensure that the dialysis prescriptions matched the treatment patients received. Failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm, injury, and denied the patients their rights. Patients: #3 and #4 Findings included: The treatment flowsheet is the form used to record the patient’s care during dialysis. Recorded information includes the patient’s blood flow rates (BFR) and the dialysate flow rate (DFR), the patient’s blood pressure, administration of medications, visual observations of the patient and any patient complaints. This information may be hand written or computer generated. According to the facility’s policy “Nursing Supervision and Delegation”, page 5: “The registered nurse must evaluate each patient preferably within an hour to: Review accuracy and completeness of treatment and patient data; Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed.” On 07/31/2024, review of the facility’s policy entitled “Patient Assessment and Monitoring” determined that page 6 stated, “Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered.” A review of five (5) patients’ treatment flowsheets on 07/31/2024, revealed that two (2) or 40% of the selected patients did not receive the correct dialysis prescription as ordered by the Nephrologist. On treatment date 07/30/2024, Patient #3’s DFR was prescribed for 500 ml/min; however, DFR was set at 800 ml/min for the entire treatment. There was no documentation from the clinical staff explaining why Patient #3’s DFR was not set on the dialysis machine as prescribed. On treatment date 07/20/2024, Patient #4’s BFR was prescribed for 400 ml/min; however, BFR was set at 350 ml/min for the entire treatment. There was no documentation from the clinical staff explaining why Patient #4’s BFR was not set on the dialysis machine as prescribed. The Clinical Manager was informed of the findings on 07/30/2024.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 44367 Based on the patient record review and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that an initial comprehensive assessment was conducted on all new patients within the latter of 30 calendar days, or 13 treatments beginning with the first outpatient dialysis session. This failure placed the affected patient at potential risk of harm and denied the patients their rights. Patients: #1 and #4 Findings included: On 07/30/2024, review of the facility’s policy entitled “Comprehensive Assessment and Plan of Care” revealed that “An initial comprehensive assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.” On 07/30/2024, review of the five (5) selected patients’ charts revealed two (2) of the selected patients’ charts did not contain an Initial Comprehensive Assessment. Surveyor noted the following during chart review: Patient #1 was admitted to the facility on 10/19/2020; however, there was no initial Comprehensive Assessment found in the Patient #1’s paper or electronic chart. Patient #4 was admitted to the facility on 10/18/2021; However, there was no initial Comprehensive Assessment found in the Patient #4’s paper or electronic chart. The Clinical Manager was informed of the findings on 07/30/2024.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 44367 Based on a review of personnel records and interviews with the facility’s administration and staff, the facility’s administration failed to ensure applicable clinical personnel were current with required certifications and annual training. This failure placed patients at potential risk for harm. Staff: 1 and #7 Findings include:. Review on 07/31/2024 of the facility’s personnel files revealed that 2 out of 24 staff members annual training was not completed annually. Documentation revealed the following: Staff #1’s Annual Clinical Skills was documented as last completed on 09/25/2024, which is a future date. Staff #7’s Annual Clinical Skills was last completed on 06/16/2022. The Clinical Manager was given multiple opportunities to provide updated information; however, no additional documentation was provided.”

“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: 44367 Based on observations, staff interviews and review of the facility’s policies and procedures, the Medical Director failed to provide effective oversight to the facility as evidenced by failure of the facility’s staff members adhered to their own policies and procedures. This failure posed a potential risk of safety to the patients and denied patients their rights to a minimum standard of medical care. Findings included: 1. On 08/01/2024, inspection of the emergency evacuation cart and crash cart revealed that six (6) out of 58 of the facility’s patients were not listed on the contact list in the event of an evacuation, the facility failed to ensure that all emergency equipment is checked and fully functioning, medications were expired. This finding failed to meet the facility’s policy titled “Emergency Medications, Equipment and Supplies.” Cross-referenced with tag E0018 and E0028. 2. On 07/30/2024, 07/31/2024 and 08/01/2024 observation of the clinical treatment area revealed Staff #3 and Staff #4 did not wear protective eyewear or gowns during the treatment termination process and Staff #3 and Staff #6 did not change gloves or conduct hand hygiene during the treatment initiation and termination process. These findings failed to meet the facility’s policy titled “Personal Protective Equipment.” Cross-referenced with tag V0113 and V0115. 3. On 07/30/2024, observation of the clinical treatment area revealed that Staff #6 did not clean the prime bucket during the disinfection of the dialysis machine after treatment termination and Staff #6 did not clean the wall box at the end of the day. The wall boxes of Stations #1, 2, 14,15, 16, and the isolation room. These findings failed to meet the facility’s policies titled “Prime Bucket Disinfection” and “Cleaning and Disinfection of the Dialysis Station.” Cross-referenced with tag V0122. 4. On 08/01/2024, observation of the clinical treatment area revealed that Staff #1 and Staff #6 did not clean the Central Venous Catheter during the treatment initiation process, according to the policy. This finding failed to meet the facility’s policies titled “Changing the Catheter Dressing Procedure” and “Initiation of Treatment Using a Central Venous Catheter.” Cross-referenced with tag V0147. 5. On 07/30/2024, inspection of the water system and the hemodialysis machines revealed that the Medical Director did not sign the culture’s results, providing review and acknowledgement of the results for January 2024, February 2024, March 2024, April 2024 and June 2024. This finding failed to meet the facility’s policy titled “AAMI Chemical Analysis of Water and Dialysis.” Cross-referenced with tag V0179. 6. On 07/30/2024 and 08/02/2024, inspection of the water treatment room revealed that the contents of bicarbonate mix tank were not labeled properly. This finding failed to meet the facility’s policy titled “Concentrate Labeling Requirements.” Cross-referenced with tag V0228. 7. On 08/02/2024, inspection of the water treatment room revealed that the contents of bicarbonate mix tank had expired. This finding failed to meet the facility’s policy titled “Bicarbonate Concentrate Mixing.” Cross-referenced with tag V0233. 8. On 07/31/2024 and 08/02/2024, observation of the clinical treatment area revealed Patient #14 machine’s air detector was not armed while the patient was receiving treatment and Staff #2 did not test the machine according to the manufacturer’s recommendation; and was not free of expired supplies. This finding failed to meet the facility’s policies titled “Priming an Optiflux Single Use E-Beam Dialyzer”, “Pre-Treatment Safety Checks Procedure,” and ‘Electronic Temperature Monitoring of the Elmer Refrigerator” Cross-referenced with tag V0403. 9. On 07/30/2024, review of the patients’ charts revealed Patient #3 and Patient #4 charts did not have an Advanced Directive or an acknowledgement form. This finding failed to meet the facility’s policy titled “Advance Directive.” Cross-referenced with tag V0457. 10. On 07/30/2024, inspection of patients’ charts revealed that Patient #3 did not have an initial nursing assessment completed. This finding failed to meet the facility’s policy titled “Patient Assessment and Monitoring.” Cross-referenced with tag V0502. 11. On 07/31/2024, review of patient’s flowsheets revealed Patient #3 and Patient #4 did not receive their dialysis treatment as prescribed by the Nephrologist. This finding failed to meet the facility’s policy titled “Patient Assessment and Monitoring.” Cross-referenced with tag V0503. 12. On 08/01/2024 during record review of the selected patients’ initial comprehensive assessment (30-day), the surveyor noted that 2 out of the 6 patients did not have an assessment completed. This finding failed to meet the facility’s policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care.” Cross-referenced with tag 0516.”