Bma - South Annapolis

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 44367 Based on observations, staff interviews and record review, the facility’s administration and the Medical Director failed to confirm that emergency equipment was available and in proper working condition; supplies and medication were secure and non-expired. This failure placed the safety and well-being of the patients at potential risk of harm in the event of an emergency evacuation. Findings included: Review on 07/18/2024 of the facility’s policy entitled “Emergency Medication, Equipment and Supplies” page 2 stated. “The emergency cart must be: Checked monthly or after use for contents, expiration dates, cleanliness and proper functioning of all equipment. On 07/18/2024 at 11:17 a.m., the Surveyor pulled the emergency cord labeled “Help”, in the home training room #1, the alarm did not sound, but the light over the door was lit. At 11:19 a.m., the Surveyor pulled the cord in the home training room #2, the alarm did not sound, but the light over the door was also lit. At 11:19 a.m., the surveyor stood outside of both doors for 10 minutes. During that time 2 staff members walked past the two door for a total of three times: however, neither staff member addressed the alarms. The Director of operations witness and corroborated the findings.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 44367 Based on clinical observations, the governing body failed to ensure that the clinical staff followed the standard regulations in the cleaning and disinfection of contaminated equipment being used in the facility. This failure put patients at risk for possible cross-contamination. Staff: #1 Findings included: Review on 07/19/2024 of the facility’s policy entitled “Prime Bucket Disinfection “ page 1 stated, “Dispose of saline solution down any marked dirty sink...Clean all surfaces of the prime bucket or approved receptacle, with 1:100 bleach solution or an approval 1:100 bleach disinfect wipe.” Observation on the clinical treatment area on 07/19/2024 revealed the following: At 11:59 a.m., Staff #1 did not clean the prime bucket during the machine disinfection process at station #4. At 12:08 p.m., Staff #1 did not clean the prime bucket during the machine disinfection process at station #1. Review on 07/19/2024 of the facility’s policy ventilated “Cleaning and Disinfection of the Dialysis Station” revealed that the “Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately is splattered with blood.” At 11:59 a.m., Staff #1 disinfected the dialysis machine at station #4 and closed the station for the day. Staff #4 did not clean the wall box. At 12:08 p.m., Staff #1 disinfected the dialysis machine at station #4 and closed the station for the day. Staff #1 did not clean the wall box. The Director of Operations was informed of the findings on 07/19/2024.”

“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 the medications being administered to patients were handled aseptically. This failure placed the patients at potential risk of infection and cross contamination. Staff: #6 Findings Included: According to the facility’s policy Medication Preparation and Administration, page 6 states “cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol. Allow to dry before inserting a device into the vial. “ Observation of the clinical treatment area on 07/18/20240 at 10:00 a.m. revealed Staff #6 punctured an open multi-dose Heparin vial without cleaning the septum per policy.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the governing body and the medical director failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #1, #3 and #8 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].” According to the facility’s policy entitled, “Changing the Catheter Dressing Procedure” page 2 states, “2% Chlorhexidine and 70% alcohol: Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds.” Page 4 states, “Inspect and remove old dressing...Discard dressing and remove gloves. Perform hand hygiene. Prepare dressing supplies...Perform hand hygiene and don gloves...” According to the facility’s policy “Initiation of Treatment Using a Central venous Catheter and Optiflux Single Use Ebeam Dialyzer” page 4 states, “Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) for 10-15 seconds and any time caps are removed, or bloodlines are disconnected (i.e. end of treatment or treatment interruption) to reduce risk of contamination.” Observation of the clinical treatment area on 07/18/2024 at 10:10 a.m. revealed that during initiation of treatment at station 18, Staff #1 cleaned catheter exit site for only 11 seconds during the dressing change. Observation of the clinical treatment area on 07/19/2024 at 11:44 a.m. revealed that while a patient was receiving treatment at station #2, Staff #1 disconnected the arterial line and the venous line and did not scrub the arterial hub or the venous hub. Staff #1 then reversed the bloodline and attached them back to the arterial and venous hubs and resumed treatment. Observation of the clinical treatment area on 07/18/2024 at 02:47 p.m. revealed that during initiation of termination at station #2, Staff #8 did not clean the arterial or venous hubs after disconnecting the bloodlines. Observation of the clinical treatment area on 07/18/2024 at 03:17 p.m. revealed that during initiation of treatment at station 14, Staff #3 cleaned catheter exit site for only 14 seconds during the dressing change. The Director of Operations was informed of the findings on 07/18/2024 and 07/19/2024.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 44367 Based on review of medical records, and interviews with the facility’s administrative staff, the governing body failed to ensure that a registered nurse (RN) completed an initial nursing assessment prior to the patients’ initial dialysis treatment when being admitted to the facility. This failure placed the affected patients at risk for harm and/or death. . Patients: #4 and #5 Findings included: Review on 07/18/2024 of the facility’s policy entitled “Comprehensive Interdisciplinary Assessment and Plan of Care” revealed that “A registered nurse must perform an assessment on patient new to dialysis before initiation of their first treatment to determine immediate needs.” During a review of six (6) selected patients’ medical records on 07/18/2024, the surveyor noted that two (2) of the selected patients’ paper or electronic charts did not contain an initial nursing assessment. The assessment should have been completed prior to the patient being placed on the dialysis machine on the day of admission. The Clinical Manager corroborated that the initial nursing assessment was not completed.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 44367 Based on review of the dialysis patients’ treatment flowsheets, the facility’s administration and clinical staff failed to ensure that the dialysis prescriptions were the same as what the patients received. Failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm, injury, and denied the patients their rights. Patients: #2 and #5 Findings included: The treatment flowsheet is the form used to record the patient’s care during dialysis. Recorded information includes the patient’s blood flow rates (BFR) and the dialysate flow rate (DFR), the patient’s blood pressure, administration of medications, visual observations of the patient and any patient complaints. This information may be hand written or computer generated. According to the facility’s policy “Nursing Supervision and Delegation”, page 5, The registered nurse must evaluate each patient preferably within an hour to : Review accuracy and completeness of treatment and patient data; Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed.” Review on 07/18/2024 of the facility’s policy entitled “Patient Assessment and Monitoring” page 6 stated, “Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct and the prescribed flow is being delivered.” A review of nine (9) patients’ treatment flowsheets on 07/18/2024, revealed that two (2) of the selected patients did not receive the correct dialysis prescription as ordered by the Nephrologist. On treatment date 07/18/2024, Patient #2’s BFR was prescribed for 400 ml/min. however, BFR was set at 300 ml/min from 12:32 p.m. to 3:10 p.m. There was no documentation from the clinical staff explaining why Patient #2’s BFR was not set on the dialysis machine as prescribed On treatment date 07/15/2024, Patient #5’s DFR was prescribed for 700 ml/min. however, DFR was set at 600 and 500 ml/min from 03:07 p.m. to 06:44 p.m. There was no documentation from the clinical staff explaining why Patient #5’s DFR was not set on the dialysis machine as prescribed. On treatment date 07/12/2024, Patient #5’s DFR was prescribed for 700 ml/min. however, DFR was set at 600 ml/min for the entire treatment. There was no documentation from the clinical staff explaining why Patient #5’s DFR was not set on the dialysis machine as prescribed. The Director of Operations was informed of the findings on 07/18/2024.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 44367 Based on the patient record review and interviews with the facility’s administration, the governing body, and interdisciplinary team (IDT) failed to ensure that an initial comprehensive assessment has been conducted on all new patients within the latter of 30 calendar days, or 13 treatments beginning with the first outpatient dialysis session for in-center and Home Dialysis. This failure placed the affected patient at potential risk of harm and denied the patients their rights. Patients: #3, #7, #8 and #9 Findings included: Review on 07/18/2024 of the facility’s policy entitled “Comprehensive Assessment and Plan of Care” revealed that “An initial comprehensive assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.” On 07/18/2024, review of the nine (9) selected patients’ charts revealed four (4) of the selected patients’ charts did not contain an Initial Comprehensive Assessment. The charts revealed the following: Patient #3 was admitted to the facility on 12/21/2022; However, there was no initial Comprehensive Assessment found in the Patient #3’s paper or electronic chart. Patient #7 was admitted to the facility on 05/24/2024; However, there was no initial Comprehensive Assessment found in the Patient #7’s paper or electronic chart. Patient #8 was admitted to the facility on 02/05/2024; However, there was no initial Comprehensive Assessment found in the Patient #8’s paper or electronic chart. Patient #9 was admitted to the facility on 09/05/2023; However, there was no initial Comprehensive Assessment found in the Patient #9’s paper or electronic chart. The Clinical Manager was informed of the findings on 07/18/2024.”