Davita Cedar Lane 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 interviews with the facility’s patients and staff, as well as a review of the facility’s policies and procedures, the governing body failed to ensure that all emergency supplies and equipment were readily available for all patients. This failure placed patients at potential risk of harm. Findings included: 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.” During observations in the clinical treatment room on 7/23/2025 at 11:57 a.m., it was noted that station #14 did not have an emergency take-off kit readily available at the patient’s station or stored within the patient’s reach. This finding was confirmed by Staff #13 when this surveyor inquired about the missing emergency take-off kit at station #14, and it was discussed with the facility administrator during the exit conference on 7/28/2025.”

“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: 36839 Based on personnel files reviewed and an interview with the facility’s administrator, the governing body failed to ensure that all staff members were trained in emergency preparedness at least annually. This failure placed all patients, staff, and visitors at potential risk of harm. Staff: #1, #4, #8, and #12 Findings included: During a review of personnel files on 7/28/2025, it was noted that 4 of 14, or 28.5% of the facility’s staff, had no updated record of having been trained in emergency preparedness policies and procedures at least annually. This finding was confirmed by the facility administrator per records that were provided to this surveyor on 7/28/2025.”

“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 facility’s administration failed to ensure that clinical staff consistently wore personal protective equipment (PPE) properly on the clinical treatment floor. This failure posed a risk of exposure to infectious diseases for both patients and staff. Findings included: Dialysis staff are required to wear appropriate PPE based on potential exposure. Ensuring that a face mask properly covers both the mouth and nose (for both clinical staff and patients) is crucial during the initiation and termination of dialysis for a patient with a central venous catheter (CVC). This practice reduces the risk of respiratory droplet transmission and helps maintain a sterile environment during the procedure, thereby contributing to the safety of both the patient and the healthcare provider. During clinical observations, the following were noted: 1. On 7/23/2025 at 3:00 p.m., the patient care technician (PCT) assigned to station #9 was wearing her mask below her nose while performing a CVC connection. 2. On 7/28/2025 at 10:45 a.m., the PCT at station #10 was wearing a face shield, but her mask was below her nose during a CVC disconnection. These findings were discussed with the facility administrator during the exit conference on 7/28/2025.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. 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 items taken to the dialysis stations were either disposed of, dedicated for use on a single patient, or cleaned and disinfected before being returned to a common clean area. This failure placed patients at potential risk of exposure to bloodborne pathogens and other infectious diseases. Findings included: The facility’s Infection Control policy (#12-07-01, page 4, #34) states: “If electronic thermometers and/or blood glucose meters are used, measures will be taken to prevent cross-contamination between patients. For example, the thermometer should not be placed on potentially contaminated equipment such as the dialysis delivery system. If the potential for contamination exists, the device’s outer casing is to be wiped with an appropriate disinfectant before being returned to a clean area or used on another patient.” During clinical observations on 7/23/2025 at 2:55 p.m., it was noted that a patient care technician obtained the patient’s temperature at station #2 and then placed the digital thermometer on top of the computer workstation without disinfecting it. This finding was discussed with the facility administrator during the exit conference on 7/28/2025.”

“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 a review of the facility’s policies and procedures related to dialysis machine cleaning and disinfection logs, and interviews with clinical staff, the governing body failed to ensure that all clinical staff followed the standard protocol for cleaning and disinfecting equipment and supplies. This failure placed all patients and staff at potential risk of exposure to bloodborne pathogens and other infectious diseases. Findings included: 1. The facility ’ s Policy 2-02-02, titled “Fresenius Dialysis Delivery System Cleaning and Disinfection,” states: “#7 At a minimum, the facility-specific log must include the following elements: -Serial number -Date procedure performed -Type of procedure performed - Cleaning/De-scaling, Disinfection -Post-chemical rinse residual test -Verification of negative chemical residual test just prior to next use -Status of equipment” A review of the facility’s dialysis machine cleaning and disinfection logs (verified with staff #14) on 7/23/2025 for the period 5/12/2025 to 7/22/2025 revealed the following: a. On 5/15/2025, 5/24/2025, 5/29/2025, and 6/28/2025, no documentation was found regarding the type of cleaning or disinfection procedure performed on all 18 dialysis machines. b. On 7/3/2025, 7/10/2025, and 7/17/2025, the post-chemical rinse residual test results were not documented. 2. The facility’s Infection Control Policy 5-06-01 (page 3) states: “12b.iv. Items disinfected via submersion will be fully submerged.” a. During observations on the clinical treatment floor on 7/23/2025 at 11:55 a.m., a clear square basin labeled as containing 1:100 bleach, located near the dirty sink facing stations #6 and #7, contained two white clamps that were not completely submerged in the solution. These findings were discussed with the facility administrator during the exit conference on 7/28/2025.”

“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, the facility’s governing body failed to ensure that every patient’s vascular access was visible during hemodialysis treatment. This failure placed patients at potential risk of harm and possible death. Findings included: During observations on the clinical floor on 7/23/2025 from 11:30 a.m. to 12:30 p.m., it was noted that the vascular access sites of the patients at stations #7 and #8 were covered with blankets and were not readily visible to the clinical staff for more than 30 minutes while the patients were undergoing dialysis treatment. A review of these patients’ treatment flow sheets on 7/23/2025 did not show any documentation indicating that clinical staff were aware that the patients’ accesses were covered, had verified that the needles were in place, or had provided teaching to the patients on the importance of keeping their access sites visible to clinical staff.”

“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 governing body and the medical director failed to ensure that all patients were provided information about creating an advance directive in a prompt manner. This failure denied patients their rights to formulate treatment decisions that addressed their end-of-life needs. Patient #2 Findings included: Advance directives establish in writing an individual’s preferences regarding the degree of medical care and treatment desired, or designate who should make treatment decisions if the individual becomes incapacitated and is unable to make or communicate medical decisions. Advance directives may include documents such as living wills and durable powers of attorney for health care (also called a health care proxy or medical power of attorney), as recognized by State law. This standard requires facilities to inform patients about advance directives, including their right to formulate one. The standard does not require that all patients have an advance directive. A review of sampled patient medical records on 7/28/2025 revealed that Patient #2 had no documentation showing that the patient was offered or provided information on creating an advance directive.”

“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 observations, review of patient records, and staff interviews, the facility’s governing body failed to ensure that the clinical staff followed the physician-ordered dialysis prescription. Failure to follow the prescribed treatment placed the patient at risk for inadequate dialysis, electrolyte imbalance, and other adverse outcomes. Findings include: The hemodialysis prescription includes the number of treatments per week, treatment duration, dialyzer, specific parameters of the dialysis delivery system (blood flow rate, dialysate flow rate, electrolyte composition of the dialysate), anticoagulation, and the patient ’ s target weight. The dialysis prescription must be implemented as ordered by the physician to ensure safe and effective treatment. On 7/28/2025 at 10:28 a.m., observation in the treatment room revealed that the patient care technician (PCT) initiating dialysis on the patient at station #6 failed to implement the prescribed dialysate bath. The patient continued dialyzing under the incorrect dialysate bath until 11:07 a.m., more than 30 minutes after treatment initiation. During an interview, the charge nurse acknowledged that she had to remind the PCT that the patient was receiving dialysis with the wrong dialysate bath.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 36839 Based on observations, the facility’s administration failed to ensure that all clinical staff adhered to established procedures for assessing and maintaining vascular access prior to cannulation. Failure to follow required vascular access assessment and infection control practices placed the patients at risk for bloodstream infection, compromised vascular access, and other adverse outcomes. Findings include: 1. The facility’s policy and procedure titled “Cannulation of Fistula or Graft” states: “Palpate access to evaluate thrill. Listen for bruit with a stethoscope. If thrill or bruit is absent, notify the charge nurse or physician prior to cannulating the access.” On 7/28/2025 at 10:30 a.m., observation in the treatment area revealed that the patient care technician (PCT) assigned to station #12 did not listen for a bruit in the patient’s vascular access prior to cannulation. 2. The facility’s policy and procedure titled “Arteriovenous (AV) Fistula or Graft Cannulation” states: “Do not palpate the insertion site once the area has been prepped. Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” On 7/28/2025 at 10:46 a.m., observation revealed that the PCT assigned to station #7 touched the patient’s needle insertion site prior to cannulation after the site had already been prepped.”

“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 review of the medical records, and the facility’s policies and procedures, the governing body and the interdisciplinary team (IDT) failed to ensure that a 30-day comprehensive assessment was 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 patient his or her rights. Patient #1 Findings included: According to the facility’s policies and procedures titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (Policy #1-14-01, page 2, #4), “A comprehensive assessment will be conducted on all new patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis), beginning with the first outpatient dialysis treatment.” Upon review of the sampled patients’ medical records with the clinical coordinator, it was noted that Patient #1, whose initial dialysis treatment at the facility was on 6/23/2025, did not have an initial comprehensive assessment completed as of 7/28/2025.”

“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 a review of the patients’ medical records and the facility’s policies and procedures, 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 patients at risk for receiving inadequate health care and denied them their rights. Patients: #3, #5, and #6 Findings included: 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.” If the comprehensive patient assessment and plan of care for an experienced dialysis patient transferring from one dialysis facility to another are received with the patient in transfer, the receiving facility’s IDT must conduct a reassessment within three months of the patient’s admission to the new facility. Upon review of the sampled patients’ medical records with the facility’s clinical coordinator on 7/28/2025, the following were noted: 1. Patient #3, who was admitted to the facility on 8/21/2024, had an initial comprehensive assessment completed on 9/26/2024; however, no 90-day reassessment was found in the patient’s medical records. 2. Patient #5, who was admitted to the facility on 8/8/2024 as a transfer from another facility of the same provider, had no follow-up 90-day reassessment documented in the medical records. 3. Patient #6 was transferred from another facility on 8/18/2023, with an initial comprehensive assessment completed on 7/21/2023 at the patient’s previous facility. However, the follow-up reassessment was not completed until 1/3/2024, which is more than 90 days after the patient’s admission to the current facility. These findings were verified with the clinical coordinator during the medical record review and were discussed with the facility administrator during the exit conference on 7/28/2025.”

“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: 36839 Based on observation and review of facility policy, the facility’s administration failed to ensure that clinical staff adhered to established procedures for assessing vascular access and implementing infection control practices prior to cannulation. This failure placed patients at risk for potential harm related to infection and compromise of vascular access. Findings include: The facility’s policy titled “Arteriovenous Fistula (AVF) or Graft (AVG) Cannulation” (1-04-01E) states: “Do not palpate the insertion site once the area has been prepped. Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” On 7/23/2025 at 2:27 p.m., observation of the dialysis treatment floor revealed that the patient care technician (PCT) assigned to station #5 palpated the patient’s vascular access insertion site immediately before needle insertion, after the site had been prepped.”

“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 a review of the facility’s staffing logs and interviews with clinical staff, the governing body failed to ensure adequate staffing patterns and failed to document staffing exception reports in a timely manner. This failure placed 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 regulation also requires that staffing exception reports 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 ensure compliance. On 7/28/2025, a review of the three-week staffing schedule from 6/30/2025 to 7/19/2025 revealed that the facility did not meet the required patient-staff ratio per state regulations on 7/4/2025, 7/5/2025, and 7/19/2025. Additionally, no staffing exception reports were provided for these dates.”