Davita Mercy Dialysis

“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: 36839 Based on observations and a review of the facility’s policies and procedures, the governing body failed to ensure that all emergency supplies and safety equipment in the facility are regularly monitored to ensure that they are complete, easily accessible, functional and free of defects. This failure placed the patients and staff at potential risk of harm, injury, or even death. Findings included: 1. According to the facility’s policy 1-10-09: Emergency take off kits are to be available at each dialysis station and stored within the patient’s reach. The emergency take off kit should include 4 hemostats (blood line clamps) and 1 pair of scissors (optional). During inspection of the emergency take off kits that were attached to each television set in the clinical treatment room on 6/20/2024, it was noted that the kits were incomplete at the following stations: Stations #3, #19, #25, #27, and the isolation room. 2. According to the facility’s policy on Fire Safety Preparedness (Policy #4-07-04): Fire extinguishers shall be checked monthly to verify it is: (a) Fully charged, (b) Safety seals are not broken or missing, (c) There is no evidence of physical damage, corrosion, leakage, or clogged nozzle, (d) Kept in its designated place at all times except during use, (e) There are no obstructions to access or visibility, (f) The fire extinguisher inspection shall be documented on the inspection tag or appropriate log. During inspection of the fire extinguishers in the dialysis treatment room on 6/20/2024, two fire extinguishers were noted to have been last inspected on 4/2024. No record was found showing that the fire extinguishers were checked during the months of May and June 2024. These findings were confirmed by the facility administrator during the exit conference on 6/21/2024.”

“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: 36839 Based on clinical observations, the facility’s administration failed to ensure that the standards of care related to hand hygiene requirements were complied with by the clinical staff. This failure placed all patients at potential risk for nosocomial infections (infections acquired while in a healthcare setting). Findings included: As per the Centers for Disease Control and Prevention (CDC), even when using gloves, it is crucial to practice hand hygiene after glove removal due to potential contamination from glove defects and the outer surface during removal. During observations in the clinical treatment room on 6/20/2024 at 1:48 p.m., the patient care technician did not perform any hand hygiene in between glove changes during the discontinuation of treatment of a patient with a central venous catheter (CVC) at dialysis station #19. This finding was discussed with the facility administrator during the exit conference on 6/21/2024.”

“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: 36839 Based on observations, the governing body failed to ensure that all the clinical staff took adequate measures in order to prevent the transmission of infectious organisms and the possibility of exposure from contaminants. This failure placed the welfare and safety of patients and staff at risk of harm. Findings included: A used personal protective equipment (PPE) is considered “contaminated” from areas that have or are likely to have been in contact with body sites, materials, or environmental surfaces where the infectious organism may reside. Therefore, when a gown or full PPE is worn, PPE should be removed prior to leaving the treatment area. 1. On 6/20/2024 at 11:10 a.m., RN #2 was observed to have exited and re-entered the clinical floor to get new biohazard sharps containers from the supply room wearing a PPE gown. 2. On 6/20/2024 at 11:52 a.m., PCT #4 was noted walking in the hallway from the clinical floor wearing a PPE gown. These observations were discussed with the facility administrator during the exit conference on 6/21/2024.”

“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: 36839 Based on observations, the governing body failed to ensure that the clinical staff followed the standard regulations in the cleaning and disinfection of contaminated surfaces and equipment being used in the facility. This failure placed the patients at potential risk for exposure to blood-borne pathogens (causative agent of disease, such as bacteria or virus, that is transmitted by blood) and infectious diseases. Findings included: Proper cleaning and disinfection in hemodialysis units are important in preventing the spread of infectious diseases and blood-borne pathogens between patients. The process of hemodialysis, which involves processing the patients’ blood outside their bodies, requires the need for strict hygiene protocols. Meticulous cleaning and disinfection are vital for patient safety and disease prevention, making it essential to promote a culture of strict adherence to protocols and ongoing improvement. The following observations were noted: 1. On 6/20/2024 at 1:55 p.m., RN #3 cleaned all equipment after the patient had already left at station #18, but did not include the emergency take-off kit that was attached to the television. 2. On 6/21/2024 at 10:24 a.m., PCT #1 obtained the patient’s temperature at station #11 where the digital thermometer was observed to have touched the skin on the left side of the patient’s neck. PCT #1 then placed the thermometer back on the computer cart without disinfecting it. These findings were discussed with the facility administrator during the exit on 6/21/2024.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 36839 Based on review of the hepatitis B tracking system logs and interviews with the facility administrator (FA), the governing body failed to ensure that the hepatitis B status was known either prior to or within 7 days of the patients’ initial dialysis treatment at the facility. This failure placed the susceptible patients at potential risk of exposure to bloodborne pathogens. Patients: #11 and #17 The findings included: Hepatitis B, a serious liver infection caused by the hepatitis B virus (HBV), can be prevented among end-stage renal disease (ESRD) patients by testing all new patients for HBV serologic status (i.e. Hepatitis B surface antigen [HBsAg], total anti-hepatitis B core [HBc] and Hepatitis B surface antibody [HBsAb]) before admission. In emergencies, patients should be tested immediately upon intake with results available within 7 days. A review of the hepatitis record audit on 6/20/2024 showed that the facility was not aware of the HBV serological status immediately prior to or within 7 days of admission on the following patients: 1. Patient #11’s first dialysis treatment at the facility was on 4/4/2024. The HBsAg of this patient was not known until 4/15/2024 which was greater that 7 days from the time of admission. 2. Patient #17’s first dialysis treatment at the facility was on 3/12/2024. No HBsAg result was found in the facility’s HBV surveillance report. These findings were verified with the FA during the exit conference on 6/20/2024.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 36839 Based on observations, the governing body failed to ensure that all clinical staff performed central venous catheter (CVC) dressing changes following their policies and procedures. This failure placed the patient at a higher risk of acquiring an infection at the CVC site. Findings included: According to the facility’s Central Venous Catheter procedure (1-04-02B) steps 4-13, dressing replacement must be performed prior to initiating dialysis treatment to allow the clinical staff to observe for signs and symptoms of infection such as redness, drainage, swelling or tenderness, as well as evidence of cuff migration, cracks or leaks in the catheter limbs. During observations on the clinical floor on 6/20/24 at 1:50 p.m., PCT #4 was noted performing a CVC dressing change on a patient at station #19 three minutes prior to the end of dialysis treatment. This was confirmed with the 2nd registered nurse upon observation, and discussed with the facility administrator during the exit conference on 6/21/2024.”

“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: 36839 Based on observations and interviews with the clinical and administrative staff, the governing body failed to ensure that all supplies used for dialysis treatment were maintained in a manner that provided for patient safety. This failure placed the affected patients at potential risk of harm. Findings included: Expiration date is the date after which a consumable product should not be used because it may be spoiled, damaged or ineffective, and therefore must be disposed of promptly to help reduce the chances that others accidentally receive or intentionally misuse them.. Most medical materials (e.g., medications, fluids, disinfectant solutions, catheters, sutures, etc.) are imprinted with an expiration date. Beyond this date, the manufacturer does not guarantee the sterility, safety, or stability of the item. During observations and inspection of supplies at various times on 6/20/2024 and 6/21/2024, the following were noted: 1. In the supply drawer located across dialysis station #24, two red-top blood collection tubes with lot #2147731 had an expiration date of 10/31/2023; one green-top blood collection tube with lot #3016654 had an expiration ate of 1/31/2024; 31 pieces of RPC blue catheter caps with lot # 2100035 had an expiration date of 4/13/2024 2. In the supply room, 8 unused/unopened bottles of ExSept antimicrobial wound cleansers had an expiration date of 4/8/2024 These were confirmed by RN #2 and PCT #11 shortly after the expired supplies were found and again discussed with the facility administrator during the exit conference on 6/21/2024.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 36839 Based on observations and staff interviews, the facility’s governing body failed to ensure that every patient’s vascular access was visible during hemodialysis treatment. This failure placed the patients at potential risk of harm and possible death. Findings included: The clinical staff must be able to see each patient, including their face, vascular access site, and bloodline connections, throughout dialysis to prevent undetected needle dislodgement or line disconnection, which could lead to severe blood loss and death. If a patient refuses to keep their access site uncovered, the facility must educate them about the risks, understand their reasons, and create a care plan to address the issue. A signed waiver does not absolve the facility of the responsibility to monitor the access site. During observations on the treatment floor on 6/21/2024 from 11:10 a.m. to 11:30 a.m., it was noted that the patients’ vascular access sites at stations #9 and #12 were covered with a blanket during dialysis treatment. This finding was confirmed by the charge nurse and again discussed with the facility administrator during the exit conference on 6/21/2024.”

“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: 36839 Based on medical record review, the facility administrator and medical director failed to ensure that all of the facility’s patients had a completed Medical Orders for Life-Sustaining Treatment Form (MOLST) in their patient records. This failure denied the patient’s rights to formulate treatment decisions that served their end-of-life needs. Patient #5 Findings included: Maryland Code 10.01.21.04B(4)E(1)(2)(3) mandates that, starting July 1, 2013, kidney dialysis centers must accept, update, and complete the Medical Orders for Life-Sustaining Treatment (MOLST) form during patient admission. When completing or updating the MOLST form, health care facilities must offer patients or authorized decision makers the opportunity to participate. If declined, the facility must document the refusal in the medical record, including the date, time, participants, and a summary of the discussion. Patients are to be informed that the MOLST form becomes part of the medical record, accessible through standard record procedures. Upon review of the sampled patients’ medical records on 6/21/2024 with the facility administrator, it was noted that Patient #5, who was admitted to the facility on 3/4/2024, did not have a completed MOLST form.”

“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: 36839 Based on medical record review, the governing body failed to ensure that all initial nursing assessments were completed by the assigned registered nurse prior to the patients’ initial dialysis treatment when being admitted to the facility. This failure placed the affected patients at risk for receiving insufficient and ineffective care, and denied the patients their rights. Patients: #4, #8, and #11 Findings included: Before starting dialysis treatment, each patient requires an initial dialysis prescription, care orders, and comprehensive baseline physical and nursing assessments completed and documented at the facility. A nursing assessment covers a range of areas: physical examination, vital signs, vascular access assessment, and overall patient condition. A review of the sampled patients’ medical records on 6/21/2024 with the facility administrator revealed the following: 1. Patient #4’s first dialysis treatment at the facility was on 9/27/2021. No initial nursing assessment was found in the patient’s medical records. 2. Patient #8’s first dialysis treatment at the facility was on 2/15/2023. No initial nursing assessment was found in the patient’s medical records. 3. Patient #11’s first dialysis treatment at the facility was on 4/4/2024. No initial nursing assessment was found in the patient’s medical records.”

“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: 36839 Based on a review of the dialysis patients’ treatment flowsheets, the facility’s administration and clinical staff failed to ensure that the dialysis prescriptions were the same as what the patients received. The failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm or injury. Patients: #1, #2, #8, and #12 Findings included: In order to have an effective dialysis treatment, the prescription order must be followed. The Blood Flow Rate (BFR), heparin order, treatment time, as well as the frequency of the patient assessment based on each facility’s policy must all be completed and documented. The reason being, an appropriate hemodialysis prescription is individualized to meet the dialysis needs of the patient. Through data collection and nursing assessment, providers can review the patient’s response to the treatment and make changes accordingly. On 6/21/2024, a review of the sampled patients’ treatment flowsheets revealed that their BFRs were not set as prescribed, and were not supported with any documentation explaining why the clinical staff deviated from the patients’ BFR prescription. 1. On treatment date 6/19/2024/2024, Patient #1’s BFR ran at between 255 to 350 mL/minute instead of the prescribed BFR of 450 mL/minute. 2. On treatment date 6/19/2024/2024, Patient #2’s BFR was set at 400 mL/minute for 1-1/2 hours of dialysis treatment instead of the prescribed BFR of 450 mL/minute. 3. On treatment date 6/19/2024/2024, Patient #8’s BFR ran between 300 to 400 mL/minute instead of the prescribed BFR of 450 mL/minute. 4. On treatment date 6/20/2024/2024, Patient #12’s BFR was set at 350 mL/minute instead of the prescribed BFR of 450 mL/minute. These findings were discussed with the facility administrator during the exit conference on 6/21/2024.”

“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: 36839 Based on patient record review, the governing body, and the interdisciplinary team (IDT) failed to ensure that a Plan of Care (PoC) had been completed 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. Patient #6 and #14 Findings included: The Centers for Medicare and Medicaid Services (CMS) require a PoC to be completed for each new dialysis patient within 30 days or 13 treatments, whichever comes first, starting from the first dialysis session. The purpose of this assessment is to provide a comprehensive evaluation of the patient’s physical, psychosocial, and medical status, which is used to develop an individualized care plan for the patient. A review of the sampled patients’ medical records with the facility administrator on 6/21/2024 revealed the following: 1. Patient #6’s initial dialysis treatment at the facility was on 2/12/2024. No PoC was documented in the patient’s medical records. 2. Patient #14’s initial dialysis treatment at the facility was on 2/26/2024. The initial PoC was not completed until 4/17/2024 which was greater than 30 days from the date of the patient’s first treatment day.”

“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: 36839 Based on review of the patients’ plans of care (PoC), the governing body failed to ensure that the facility’s interdisciplinary team (IDT) completed the 90-day follow-up comprehensive assessment. This failure placed the affected patient at risk for receiving inadequate health care and denied the patient his/her rights. Patients: #3, #6, and #8 Findings included: The IDT should conduct a comprehensive PoC 90 days after establishing the initial PoC. This assessment evaluates health changes, PoC effectiveness, and identifies new needs. Collaborating with the patient (or designee), a nephrologist, nurse, social worker, and dietitian ensures proper addressing of patient needs and PoC adjustments if health status changes. For experienced dialysis patients moving to a new facility, the receiving IDT must reassess within three months of admission. According to the facility’s policy (1-14-01, page 2, #5), “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.” Upon review of the sampled patients’ medical records with the facility administrator on 6/21/2024, the following were noted: 1. Patient #3’s first dialysis treatment at the facility was on 9/26/2022 with an initial (30-day) PoC conducted on 10/28/2022; however, the follow-up PoC was not done until 2/28/2023 which was greater than 90 days from the date of the initial PoC. 2. Patient #6’s first dialysis treatment at the facility was on 2/12/2024. No 90-day PoC was found in the patient’s medical records. 3. Patient #8’s first dialysis treatment at the facility was on 2/25/2023 with an initial (30-day) PoC conducted on 3/30/2023; however, the follow-up PoC was not done until 7/19/2023 which was greater than 90 days from the date of the initial PoC.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 36839 Based on review of the facility staffing logs and interviews with the clinical staff , the facility’s governing body failed to ensure adequate staffing patterns, and failed to document staffing exception reports in a timely manner. This failure placed the patients’ well-being and safety at risk. Findings included: The Code of Maryland Regulations 10.05.04.06C(1)(a)(b)(c)(i)(ii) for Freestanding Kidney Dialysis Centers states “Dialysis Monitoring. Staffing Ratio. The monitoring individual-to-patient ratio at each center shall be a minimum of one staff member to three participants (patients) and staffing shall be sufficient to meet the needs of patients. The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. The charge nurse may not be included in the staffing ratio except when there are nine or fewer patients; or in the event of an emergency.” The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with this regulation. On 6/21/2024, a review of the 3-week staffing schedule from 6/3/2024 to 6/19/2024 revealed that the facility did not comply with the patient-staff ratio per state regulations on 6/3, 6/4, 6/5, 6/10, 6/11, 6/14, 6/18 and 6/19/2024 with a total of 13 out of 38 shifts or 34%. Additionally, the facility administrator (FA) was unable to provide a staffing exception report for each day the facility did not meet the staffing requirements. These findings were discussed with the FA during the exit conference on 6/21/2024.”