Davita Whitesquare Dialysis

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(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:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], 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 RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. 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 emergency evacuation kit could be easily transported during an emergency evacuation.This failure placed the safety and well-being of the patients at potential risk of harm in the event of an emergency. Findings included: Review on 12/19/2023 of the facility’s policy 4-07-01 entitled “Facility Emergency Management Plan” revealed that “The evacuation kit(s) should be portable, made of sturdy material, and easy to transport labeled Evacuation kit.” During inspection of the facility’s evacuation kit on 12/19/2023 at 12:30 a.m., the surveyor noted that the emergency evacuation kit was approximately 4 1/2 feet long, 2 feet wide, and 3 foot depth. The kit was full with enough supplies to cover 19 stations, which made the kit very heavy and difficult to move. On 12/19/2023 at 1:00 p.m., the Charge Nurse informed the surveyor that the kit was “too hard to move.” The Facility Administrator was informed of the findings on 12/19/2023.”

“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 and the governing body, the facility’s administration failed to ensure that all emergency supplies and equipment were readily available and secured to ensure availability. This failure placed patients at potential risk of harm and danger during a life threatening situation. Findings include: Review on 12/19/2023 of the facility’s policy 12-02-08 entitled “Emergency Equipment Checks” revealed that “daily checks should include ensuring that the facility’s AED is in working order as well as ensuring that the breakaway lock is intact; weekly checks should include ensuring adequate oxygen supply; and monthly checks should include ensuring supply expiration.” 1. On 12/19/2023, inspection of the facility’s crash cart revealed the following: · The crash cart was not locked. · One pack of Stat Padz II Adult Electrodes, lot number 3621A, expired 9/4/2023. · The AED was not checked daily. No documentation was completed to show the AED checks were conducted. 2. On 12/19/2023, inspection of the emergency evacuation kit revealed a bag labeled “PD” contained the following expired supplies: · One bottle of Exsept, lot number 230102, expired 1/2/2023 · One bottle of Alcavis 50, lot number 230707, expired 7/7/2023 · Six (6) Drain bags that were not in it’s original packaging. The drain bags did not have a lot number or expiration date. · One Dianeal Low Calcium PD Solution, lot number Y386739, expired 8/2023 The Facility Administrator was informed of the findings on 12/19/2023.”

“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 it’s medications were safe and that expired medications were removed from the available supplies. This failure placed the patients at potential risk to receive expired medications that may cause harm. Findings include: Review on 12/19/2023 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 12/19/2023, inspection of the facility’s medication supply revealed the following: 1. One (1) opened vial of Epogen 10,000 units/1 ml was not labeled with an expiration date or initials. 2. 25 vials of Gentamicin 80 mg/2 ml, lot number 6128207, expired 9/2023. 3. One (1) vial of Dextrose 50% injection, lot number 29004EV, expired 5/1/2023. The Facility Administrator was informed of the findings on 12/19/2023.”

“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 performed the appropriate catheter care techniques according to the policies and procedures.This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #2 and #4 Findings include: The two most common routes of catheter infection as (1) migration of skin organisms through the insertion site and into the cutaneous catheter tract resulting in colonization of the catheter tip; and (2) contamination of the hub, resulting in intraluminal colonization of the catheter. The initiation and termination of the dialysis process and manipulation and tension on the catheter provide frequent opportunity for such contamination. Catheter hubs should be disinfected again after disconnecting from bloodlines. This should be done in a manner similar to that used when disinfecting the hub prior to accessing. Review on 12/20/2023 of the facility’s policy 1-04-02B entitled “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps” the clinical staff must “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. Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly...Clean exit site with 2% Chlorhexidine Gluconate 70% Isopropyl Alcohol swab for a minimum of 30 seconds...Then wait 60 seconds for air dry time.” 1. During observation of the clinical treatment area on 12/20/2023 at 10:29 a.m., the surveyor noted that during initiation of treatment of a CVC patient at station 8, Staff #2 cleaned the exit site with 2% Chlorhexidine Gluconate 70% Isopropyl Alcohol for 10 seconds and did not allow the exit site to dry before placing a clean dressing. 2. During observation of the clinical treatment area on 12/20/2023 at 10:35 a.m., the surveyor noted that during initiation of treatment of a CVC patient at station 10, Staff #4 cleaned the exit site with 2% Chlorhexidine Gluconate 70% Isopropyl Alcohol for 20 seconds and did not allow the exit site to dry before placing a clean dressing. Staff #4 disinfected the arterial hub with an alcohol pad for only 5 seconds and the venous hub for 4 seconds. The Facility Administrator was informed of the findings on 12/20/2023.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 44367 Based on observations, the facility’s administration and the Medical Director failed to ensure that the clinical staff performed manual pH testing before initiating the treatment of each patient.This failure placed the patient affected at potential risk of harm. Staff: #3 and #5 Findings Included: Review on 12/18/2023 of the facility’s policy 2-08-01B entitled “Operation of Portable Myron L Conductivity Meter” revealed that the “Manual pH testing must be performed prior to each patient treatment.” 1. During observation of the clinical treatment area on 12/18/2023 at 1:58 p.m., the surveyor noted that Staff #5 did not check the manual pH of the dialysis machine at station 3, prior to initiating the patient’s treatment. 2. During observation of the clinical treatment area on 12/18/2023 at 2:23 p.m., the surveyor noted that Staff #3 did not check the manual pH of the dialysis machine at station 7, prior to initiating the patient’s treatment. The Facility Administrator was informed of the findings on 12/18/2023.”

“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 that the walls of Peritoneal Dialysis area was free from defects. This failure placed the patients, staff, and visitors at potential risk of harm. 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. On 12/19/2023, inspection of the facility’s Peritoneal Dialysis treatment room 2 revealed a large black stain on the wall behind the patient treatment chair.The stain was approximately three (3) feet long six (6) inches in width. 2. On 12/18/2023, inspection of the facility’s lobby revealed stains and dust on the floor and the corners at the base of the walls. 3. On 12/18/2023, inspection of the facility’s lobby revealed a loose tile directly above the entrance lobby door. The Facility Administrator was informed of the findings on 12/18/2023.”

“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. 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 12/18/2023 at 11:30 a.m. revealed the following: 1. Eight (8) packages of 17 gauge Safety Needles, lot number 17D24A, expired 3/31/2023. 2. Four hundred (400) Recirculation Caps, lot number 2000096, expired 4/28/2023. 3. One (1) Wound Culture Swab, lot number 1M07A, expired 12/7/2023. 4. One (1) 30 ml syringe, lot number 8144975, expired 4/30/2023 5. One (1) Spectrum DNA, lot number A053, expired 9/1/2022 6. Eight (8) Tiger top Blood Collection Tube, Lot Number 377311622, expired 10/31/2023 7. Ten (10) Red top Blood Collection Tubes, lot number 2161736, expired 10/31/2023. 8. Ten (10) Red top Blood Collection Tubes, lot number 2161734, expired 6/30/2023. 9. Ten (10) Red top Blood Collection Tubes, lot number 1236667, expired 1/31/2023. 10. One set (two bottles) of Blood Culture Kit, lot number 3060889, expired 11/30/2023 11. One set (two bottles) of Blood Culture Kit, lot number 3011325, expired 10/13/2023 The Facility Administrator was informed of the findings on 12/18/2023.”

“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. Patient: #1, #2, #3, #6 and #7 Findings included: A nursing assessment consists of weight (pre and post), includes a physical examination, the measurement of vital signs, observation of the vascular access and assessment of a patient’s general condition. It also includes a neurological assessment of the level of alertness and the mental status of the patient, subjective complaints, pain status, activity levels, assessment of the respirations, including auscultation of breath sounds; assessment of cardiac status to include auscultation of the heart sounds, fluid gains, skin color and temperature and bowel sounds. The RN on duty must make and document an initial assessment of the newly admitted patient prior to his or her first treatment. Review on 12/20/2023 of the facility’s policy 1-03-07 entitled “New Patient Pre-Treatment Evaluation” revealed that “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.” Review on 12/20/2023 of the selected patients’ charts revealed that 5 out of 11 of the patient did not have an initial nursing assessment completed. The Facility Administrator corroborated that the initial nursing assessment were not completed on Patients #1, #2, #3, #6 and #7.”

“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 new 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: #10 and #11 Findings included: Review on 12/19/2023 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 two (2) selected Peritoneal Dialysis (PD) patients’ plans of care (PoC) on 12/19/2023, the surveyor noted that Patient #10 and Patient #11 did not have a 30-day PoC completed. The PD Charge Nurse corroborated that both Patients #10 and #11 did not have a 30-day PoC completed after being admitted to the PD unit. The Peritoneal Dialysis Manager was informed of the findings during the exit conference on 12/20/2023.”

“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: #10 and #11 Findings included: Review on 12/19/2023 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.” During a review of the two (2) selected Peritoneal Dialysis (PD) patients’ plans of care (PoC) on 12/19/2023, the surveyor noted that Patient #10 and Patient #11 did not have a 90-day PoC completed.The PD Charge Nurse corroborated that both Patients #10 and #11 did not have a 90-day PoC completed after the initial (30-day) PoC was completed. The Peritoneal Dialysis Manager was informed of the findings during the exit conference on 12/20/2023.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 44367 Based on review of the Peritoneal Dialysis (PD) Quality Assessment and Performance Improvement (QAPI) meeting minutes and data and review of the agency’s policies and procedures, the governing body and the Medical Director failed to ensure the facility’s interdisciplinary team (IDT) adjust action plans to related access infections when goals were not being met. This failure denied patient effective and safe dialysis which placed the patients at risk for harm and/or death. Findings include: Review on 12/20/2023 of the facility’s policy 1-14-06 entitled “Continuous Quality Improvement Program” revealed that “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not limited to, the following: Infection Control, including incidence of infections, Vascular access, Mortality Review - review of deaths, Hospitalizations and Emergency Ambulance Transfers; Page 2 number 8 states, “Continuous monitoring of above indicators will be reflected in the meeting minutes, Any area identified as underperforming will be reviewed to identify root cause for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvement and sustained”; Number 9 states, “Each action plan will be evaluated as priority with Patient Safety and Clinical Outcomes indicators for the highest priority.” During review on 12/20/2023 of the Peritoneal Dialysis Quality Assessment and Performance Improvement (QAPI) meeting minutes from January 2023 through November 2023, the surveyor noted that the facility did not make goal for the Peritonitis rate from February 2023 through November 2023. Despite not making goal, the facility did not make adjustments to the action and intervention plan for peritonitis. From February 2023 through November 2023, the action and intervention plan was documented as “Pts to demonstrate technique on a quarterly basis as per protocol.” The PD Charge Nurse corroborated that the action plan was not adjusted to decrease the peritonitis rate. The PD Manager was informed of the findings on 12/20/2023 during the exit conference.”