Davita Coral Hills Dialysis

“Policies/Procedures for Medical Documentation CFR(s): §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(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:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[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. This Standard is not met as evidenced by: 44367 Based on observations, staff interview, and record review, the facility’s administration and the Medical Director failed to ensure that the patient’s health records remained confidential and protected from unauthorized access. This failure denied the patients their rights to privacy and confidentiality of their health information. Findings Included: According to the facility’s policy “Facility Emergency Management Plan” page 21 number 2 states, “2. Digital and hard copy patient medical records shall be secured at all times from unauthorized use”; Number 3 states, “Health Insurance Portability and Accountability Act (HIPAA) policies will be followed to maintain patient privacy, policy access, use, and disclosure of protected health information.” On 12/04/2024 at 12:10 p.m., during the inspection of the facility’s emergency equipment, the surveyors observed two binders containing patient information including treatment orders and medication list placed on top of the emergency evacuation kits, making it accessible for unauthorized access. The Facility Administrator was informed of the findings on 12/04/2024.”

“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 and interviews with facility staff, the governing body, the facility’s administration failed to ensure that the home training department had emergency equipment immediately available for it’s patients. This failure placed patients at potential risk of harm and/or death during a life threatening situation. Findings include: The facility must have a process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator (AED), artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. 1. Observation of the Peritoneal Dialysis (PD) unit on 12/04/2024 revealed that the unit did not have any emergency equipment. According to the PD Nurse, the unit relies on the in-center dialysis unit’s emergency equipment. In order for the PD staff to utilize the emergency equipment, they would have to walk to the left down (approximately 40’ or more), go though a door and then through a second door to enter the clinical treatment area. Then walk pass the nurses station to the middle of the unit to then retrieve the crash cart and AED. Therefore, the AED and crash cart are not immediately available for the PD unit. 2. Observation of the PD unit on 12/04/2024 revealed that the PD unit did not have an evacuation kit for its patients in the event of an emergency evacuation. The PD Nurse corroborated that the PD unit did not have a crash cart, AED, or an emergency evacuation bag.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 44367 Based on observation and review of the facility’s policies and procedures, the facility’s administration failed to ensure that the facility provided and maintained a safe treatment environment for its patients by ensuring the facility conduct fire drills quarterly per the facility’s policy. This failure placed the patients and visitors at potential risk of harm in the event of a fire. Review on 12/05/2024 of the facility’s policy 4-07-01 entitled “Facility Emergency Management Plan” revealed, “Fire safety drills: Required on a Quarterly basis.” During review of the emergency preparedness binder on 12/04/2024, the surveyor noted that the facility conducted a fire drill on 09/06/2024 and 11/23/2024. There were no fire drills documented before 09/06/2024. The Facility Administrator was given the opportunity to provide additional information; However, no additional documentation was provided. The Facility Administrator corroborated that the facility has not conducted fire drills quarterly as required per policy.”

“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 observations and a review of the facility’s policies and procedures, the governing body failed to ensure that the clinical staff followed the standard regulations in the cleaning and disinfection of contaminated surfaces in the facility. This failure placed the patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Findings included: Review on 12/04/2024 of the facility’s policy 1-05-01 entitled, “Infection Control for Dialysis Facilities” states that, “At the end of each treatment, the dialysis station will be cleaned and disinfected...1. The Wall Box, Drain and Water supply lines are considered part of the dialysis delivery system.” 1. During observation of the clinical treatment area on 12/04/2024 at 10:44 a.m., the surveyor observed white residue on the drain ports and the surface of the wall boxes at the unoccupied stations #3, #5, #6 and #8. The Facility Administrator was informed of the findings on 12/04/2024.”

“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 failed to ensure that all the multi-dose medications were safe and labeled correctly when opened. This failure placed the patients at potential risk to receive expired medications that may cause harm. Findings include: Review on 12/04/2024 of the facility’s policy 1-06-01 entitled “Medication Policy” revealed that “Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day...Medication containing a preservative must be discarded 28 days after opening or accessed...Each vial is labeled with the initial of the persons opening the vial and the expiration date.” On 12/04/2024, inspection of the facility’s Peritoneal Dialysis medication supply revealed one (1) opened vial of Epogen 10,000 units/1 ml was not labeled with an expiration date or initials. On 12/05/2024, inspection of the facility’s in-center medication supply revealed one (1) opened vial of Epogen 10,000 units/1 ml was not labeled with an expiration date or initials. The Facility Administrator was informed of the findings on 12/04/2024 and 12/05/2024.”

“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: #3 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 on 12/04/2024 of the facility’s policy 1-04-02B entitled “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps” states to “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason.” During observation of the clinical treatment area on 12/04/2024 at 11:15 a.m., during initiation of treatment of a CVC patient at station 19, Staff #3 clean the venous for one second and the arterial hub for one second after removing the caps and before attaching a clean 10 ml syringe. The Facility Administrator was informed of the findings on 12/04/2024.”

“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: Review on 12/04/2024 of the facility’s policy, “AAMI Chemical Analysis of Water and Dialysis” page 5 states, “Medical Director must review and sign each chemical analysis report obtained during the review period.” Review on 12/04/2024 of the facility’s monthly RO water, dialysate, HD machine culture reports and an interview with the Biomedical staff and the Facility Administrator revealed that the medical director did not sign and date (proof of acknowledging the culture collection results during the review period) reports for July 2024. The Biomedical Technician and the Facility Administrator corroborated that the culture reports were not signed by the medical director.”

“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: 44367 Based on observations and interviews with staff, the facility’s governing body failed to ensure the water treatment room was clean and free from defects. This failure placed the patients staff, and visitors at potential risk of harm including injury or infection. Findings Included: All buildings and building systems must be maintained free from defects and/or hazards to ensure safety and functionality. The integrity of all surfaces, (e.g., countertops, floors, walls) must be intact, clean, and free from damage. Intact surface integrity allows for effective cleaning and free from damage. Intact surface integrity allows for effective cleaning and limits the potential for microbial growth on a porous surface. 1. Inspection of the water treatment room on 12/03/2024 at 11:18 a.m. revealed the following: · Gross amount of black, brown build up on the entire surface of the drain under valve K4 and K3. · Gross amount of black, brown build up on the entire surface of the drain next to the expansion tank. · Debris and black and brown build up throughout the entire water room floor and the supply room floor · Gross amount of white and brown color substance on the entire surface of a two tier black cart · Large white container with approximately 25 white bottles with yellow caps (bleach bottles used to dispense bleach in the hemodialysis machines). The white container had a black substance inside at the bottom and the bleach bottles were on top of the black substance. The Facility Administrator and the Biomedical Technician were informed of the findings on 12/03/2024.”

“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 observation of the facility’s supplies and a review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the facility was free of expired supplies and ensured equipment checks are completed according to it’s own policy. This failure placed the patients at potential risk of harm. Findings include: When medications and supplies are no longer needed, they should be disposed of promptly. Healthcare providers should remove expired medications and supplies as quickly as possible to help reduce the chances that others accidentally receive or intentionally misuse them. Inspection of the facility’s supplies on 12/03/2024 and 12/04/2024 revealed the following expired supplies: · One bottle of Chlorine & Chloramines Test Strips expired 11/30/2024; However, the bottle was opened and labeled “12/2/2024” with the initials “LMH.” · 30 packs of Flexicap Disconnect Cap with Povidone-Iodine, lot number 24C22H26, expired 02/2024. Review on 12/05/2024 of the facility’s policy 12-08-07 entitled “Medication Requiring Refrigeration” stated “The refrigerator is checked, during facility normal operating hours, by a licensed nurse or teammate or designee...Twice daily temperature checks...at the beginning and end of the day.” Review on 12/05/2024 of the facility’s procedure 5-07-23A entitled “Medication Refrigerator Temperature Log” revealed the following missing documentation for the medication refrigerator labeled “IDPN”: On 06/03/2024, there was no documentation for the beginning or the end of the day temperature. On 06/13/2024, there was no documentation for the end of the day temperature. On 06/14/2024, there was no documentation for the beginning or the end of the day temperature. On 06/19/2024, there was no documentation for the end of the day temperature. On 06/21/2024, there was no documentation for the end of the day temperature. On 06/23/2024, there was no documentation for the end of the day temperature. On 06/24/2024, there was no documentation for the beginning or the end of the day temperature. On 06/28/2024, there was no documentation for the beginning or the end of the day temperature. On 06/30/2024, there was no documentation for the beginning or the end of the day temperature. Missing documentation for the medication refrigerator labeled “Med-Ref #1”: On 06/03/2024, there was no documentation for the beginning or the end of the day temperature. On 06/11/2024, there was no documentation for the beginning or the end of the day temperature. On 06/12/2024, there was no documentation for the beginning of the day temperature. On 06/14/2024, there was no documentation for the beginning or the end of the day temperature. On 06/17/2024, there was no documentation for the end of the day temperature. On 06/19/2024, there was no documentation for the end of the day temperature. On 06/21/2024, there was no documentation for the beginning or the end of the day temperature. On 06/23/2024, there was no documentation for the end of the day temperature. On 06/24/2024, there was no documentation for the beginning or the end of the day temperature. On 06/28/2024, there was no documentation for the beginning or the end of the day temperature. On 06/30/2024, there was no documentation for the beginning or the end of the day temperature. The Facility Administrator was informed of the findings on 12/03/2024, 12/04/2024, and 12/05/2024.”

“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: 44367 Based on observations, the facility’s administration failed to ensure that a copy of the address, and contact numbers of the State Survey Agency (SSA), was prominently displayed where it can be easily seen and read by the patients, and/or patient advocates. This failure denied the patients their rights. Findings included: The Office of Health Care Quality (OHCQ) located at 7120 Samuel Morse Drive, Second Floor, Columbia, MD 21046, contact number is (410) 402-8015 and the Quality Insights Renal Network 5, which is P.O. Box 29274, Henrico, VA 23242 and contact number is (804) 320-0004. Both must be easily accessed by patients, caregivers, advocates, and staff to make complaints and/or make inquiries regarding the services provided by dialysis facilities. During observation of the patient’s waiting room on 12/03/2024 at 01:00 p.m., the surveyor noted that the complaint information of the SSA/Office of Health Care Quality (OHCQ) was not posted and easily seen by patients, visitors, and staff. The Facility Administrator was informed of the findings on 12/03/2024.”

“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 record review of medical records, the Facility’s Administration and the Medical Director failed to ensure that initial nursing assessments were performed by the assigned registered nurse prior to the patients’ initial dialysis treatment when being admitted to the facility. This failure placed the affected patient(s) at risk for receiving insufficient and ineffective care, and denied the patients their rights. Patients: #1, #3 and #5 Findings included: The facility’s policy 1-03-07 “New Patient Pre-Treatment Evaluation” page 1 states, “An RN, as required by federal regulation, will perform an initial pre-treatment evaluation of all new patients prior to the initiation of their first treatment at the facility.” During inspection of the patients’ charts on 12/03/2024, the surveyor noted that 3 out of the 6 (43%) selected patients did not have an initial nursing assessment or the assessment was completed after the first treatment. · Patient #1 was admitted to the facility on 12/13/2021. No initial nursing assessment was found in Patient #1’s paper or electronic chart. · Patient #3 was admitted to the facility on 10/16/2023. No initial nursing assessment was found in Patient’s #3 paper or electronic chart. · Patient #5 was admitted to the facility on 11/02/2024. No initial nursing assessment was found in Patient’s #5 paper or electronic chart. The Facility Administrator was informed of the findings on 12/03/2024.”

“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 patients’ medical record reviews and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that an initial comprehensive assessment and Plan of Care (POC) was completed for all in-center patients within the latter of 30 calendar days or 13 Hemodialysis sessions beginning with the first outpatient dialysis session. This failure placed the affected patients at potential risk of harm and denied patients their rights. Patients: #1, #2, #3 and #4 Findings included: Review on 12/03/2024 of the facility’s policy 1-14-01 entitled “Patient Assessment and Plan of Care,” revealed that “A comprehensive assessment will be conducted on all patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” On 12/03/2024, during a review of the five (5) selected in-center hemodialysis (ICHD) patients’ plans of care (PoC), the surveyor noted that four out of the five patients did not have a 30-day PoC completed. The documentation revealed the following: · Patient #1 was admitted to the facility on 12/13/2021. Patient #1’s paper or electronic chart did not contain a 30-day PoC. · Patient #2 was admitted to the facility on 02/24/2023. Patient #2’s paper or electronic chart did not contain a 30-day PoC. · Patient #3 was admitted to the facility on 10/16/2023. Patient #3’s paper or electronic chart did not contain a 30-day PoC. · Patient #4 was admitted to the facility on 08/28/2021. Patient #4’s paper or electronic chart did not contain a 30-day PoC. The Facility Administrator corroborated that the four identified patients did not have a completed 30-day PoC.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 44367 Based on the patients’ medical record reviews and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that a 3 month (90-day) comprehensive assessment and Plan of Care (PoC) was completed 3 months after the completion of the initial (30-day) comprehensive assessment and PoC. This failure placed the affected patients at potential risk of harm and denied patients their rights to effective care. Patients: #1 and #2 Findings included: Review on 12/03/2024 of the facility’s policy 1-14-01 entitled “Patient Assessment and Plan of Care”, revealed that “A follow-up 90-day reassessment will be completed to evaluate the patient’s status and provide information to adjust the patient’s plan of care.” Review on 12/03/2024 of the six (6) selected patient in-center and peritoneal dialysis patients’ medical records revealed that 2 out of the 6 selected patients did not have a 90-day PoC. the following: · Patient #1 was admitted to the facility on 12/13/2021. Patient #1’s paper or electronic chart did not contain a 90-day PoC. · Patient #2 was admitted to the facility on 02/24/2023. Patient #2’s paper or electronic chart did not contain a 90-day PoC. The Facility Administrator corroborated that the two identified patients did not have a 90-day PoC completed.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- (1) At least annually for stable patients; This Standard is not met as evidenced by: 44367 Based on the patients’ medical record reviews and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that an annual comprehensive assessment and Plan of Care (PoC) was completed one (1) year after the completion of the 90-day comprehensive assessment and PoC. This failure placed the affected patients at potential risk of harm and denied patients their rights to effective care. Patient: #2 Findings included: Review on 12/03/2024 of the facility’s policy 1-14-01 entitled “Patient Assessment and Plan of Care”, revealed that “A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: At least annually for stable patients...” Review on 12/03/2024 of the six (6) selected patient in-center and peritoneal dialysis patients’ medical records revealed that 1 out of the 6 selected patients did not have an annual PoC completed. The documentation revealed the following: · Patient #2 was admitted to the facility on 02/24/2023. Patient #2’s paper or electronic chart did not contain an annual PoC. The Facility Administrator corroborated that the one identified patient did not have an annual PoC completed.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 44367 Based on the patients’ medical record reviews and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that monthly comprehensive assessments and Plan of Care (PoC) were completed on a patient who received an unstable assessment. This failure placed the affected patients at potential risk of harm and denied patients their rights to effective care. Patient: #1 Findings included: Review on 12/03/2024 of the facility’s policy 1-14-01 entitled “Patient Assessment and Plan of Care”, revealed that an assessment should be completed “Monthly (unstable patients): Monthly until patient is determined by interdisciplinary team to be stable.” Review on 12/03/2024 of the six (6) selected patient in-center and peritoneal dialysis patients’ medical records revealed that Patient #1 had an unstable assessment on 04/06/2023; However, there were no monthly assessments documented. An assessment was completed on 10/01/2024 after the patient was documented as unstable on 04/06/2023. The Facility Administrator corroborated that monthly assessments were not completed on Patient #1.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the facility’s administration and the Medical Director failed to ensure that the clinical staff complied with the appropriate procedures when assessing the patients’ vascular access prior to cannulation and practiced the correct infection control protocol. This failure placed the safety and well-being of the patients at potential risk of harm in maintaining their vascular access. Staff: #1, #2 and #6 Findings included: Review on 12/03/2024 of an article entitled “Aneurysmal Dilatation of Dialysis Arteriovenous Access” from “The Open Urology and Nephrology Journal” states “If an aneurysm has normal overlying skin and does not compromise cannulation, management consists of avoiding cannulating the aneurysm and continued observation. A careful assessment is mandated to identify the cannulation site, away from the aneurysmal area and educating the dialysis staff.” Review on 12/03/2024 of the facility’s policy entitled “Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Access Care” states “1. Inspection of the AVF or AVG access includes the following: Aneurysms and/or pseudoaneurysms...13. Cannulation sites will be rotated every treatment to avoid deterioration of access or formation of aneurysms...” Review on 12/04/2024 of the facility’s policy 01-04-01E entitled “Cannulation of Fistula or Graft” states “Do not palpate insertion site once are has been prepped. Rationale: Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” Review on 12/04/2024 of the facility’s policy entitled “AV Fistula or Vein Graft - Initiating Dialysis for Mature Access” states that, “Before initiating dialysis the Dialysis Tech or nurse shall determine the integrity of the vascular access by palpating for a thrill and auscultating for a bruit...Aseptic technique shall be followed when initiating dialysis.” 1. Observation of the clinical treatment area on 12/03/2024 at 10:55 a.m. revealed that during treatment initiation of a AVF/AVG patient at station 10, Staff #6 cannulated directly in the areas of the access that resembles an aneurysm for the arterial and the venous line. 2. Observation of the clinical treatment area on 12/04/2024 at 10:42 a.m. revealed that during treatment initiation at station #15, Staff #1 palpated the patient’s access after cleaning prior to cannulation. Staff #1 did not re-clean the access. 3. Observation of the clinical treatment area on 12/04/2024 at 10:58 a.m. revealed that during treatment initiation at station #13, Staff #2 did not auscultate the patient’s access for a bruit prior to cannulation. The Facility Administrator was informed of the findings on 12/03/2024 and 12/04/2024.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 44367 Based on the patients’ medical record reviews and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that an initial comprehensive assessment and Plan of Care (POC) were completed for all Peritoneal Dialysis (PD) patients within 30 days of the admission date. This failure placed the affected patients at potential risk of harm and denied patients their rights. Patients: #6 Findings included: Review on 12/03/2024 of the facility’s policy 1-14-01 entitled “Patient Assessment and Plan of Care,” revealed that “A comprehensive assessment will be conducted on all patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” During a review of the five (6) selected in-center hemodialysis (ICHD) patients’ plans of care (PoC) on 12/03/2024, the surveyor noted that one (1) PD patients did not have a 30-day PoC completed. The documentation revealed the following: Patient #6 was admitted to the facility on 08/06/2024. Patient #6’s paper or electronic chart did not contain a 30-day PoC. The Facility Administrator and the PD Charge Nurse were informed of the findings on 12/03/2024.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. 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 patient’s medical records were completed and accurate. This failure placed patients at risk of infective care. Patients: #3 Findings included: Review on 12/03/2024 review of the facility’s policy 3-02-02 entitled “Medical records Documentation Guidance” revealed “All handwritten entries must be legible in the medical record...Do not chart in advance (before the service, observation or order)...Document accurately and concisely but completely.” Review on 12/03/2024 of selected Patient #3’s chart revealed that the Hemodialysis Consent form was incomplete. The form did not have a date to reveal when the form was signed. The surveyor could not validate that the consent form was completed prior to Patient #3 receiving their first dialysis treatment. The Facility Administrator was informed of the findings on 12/03/2024.”