Bma - Camp Springs

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 44367 Based on the overall findings of the survey, the facility’s Governing Body, Administration and the Medical Director failed to meet the Conditions for Coverage (CfC: 494.60) for Physical Environment, as evidenced by: 1) failure to ensure that the facility’s building was maintained clean and free of defects, and 2) failure to ensure that all the dialysis machines used for patient care were assembled, tested and maintained per manufacturer’s recommendation and facility policy. This failure placed all patients at increased risk for harm and/or injury. The findings include: 1. The facility failed to ensure that the facility’s building were maintained intact, clean, and defect free. Cross-reference to findings in tag V0402: Physical Environment - Building-Construct/maintain For Safety. 2. The facility failed to ensure that staff assembled and maintained the dialysis machines in accordance with manufacturer instructions and facility policy. Cross-reference to findings in tag V0403: Physical Environment - Equipment Maintenance.”

“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 review of the facility’s personnel files, and interviews with the facility’s administration, the governing body, medical director, and facility’s administration failed to ensure that the all of the facility’s clinical staff maintained the Basic Life Support/Cardiopulmonary Resuscitation (BLS/CPR) card. These failures denied patients their rights, and posed a potential risk of harm to patients. Staff: #4 Findings include: Staff must maintain current CPR (Cardiopulmonary Resuscitation) certification for healthcare providers through a CPR provider whose training includes hands-on practice and in-person skills assessment. Occupational Safety and Health Agency (OSHA), institutions, and States, have determined that online-only certification is not acceptable. Review of the facility’s personnel files on 01/17/2025 revealed that Staff #4 did not have an acceptable BLS/CPR certification. According to the interview with Staff #4, the CPR course was taken online only on 07/17/2023. Facility documentation showed that Staff #4 worked as a Patient Care Technician providing direct care. Staff #4 has consistently worked in the clinical treatment area providing direct patient care from 07/17/2023 until 01/17/2025. According to the Clinical Manager, he/she was unaware that Staff #4 did not possess the proper certification, but did notice that “everyone else’s card did look different” and because of the difference the Clinical Manager informed Staff #4 that he/she needed to obtain a “new card right away.” The Clinical Manager corroborated that Staff #4 did not possess an acceptable BLS/CPR certification and Staff #4 was removed from the schedule until an updated BLS/CPR card is obtained.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 44367 Based on observations and interviews with facility staff, the facility’s administration failed to ensure that the clinical staff took adequate measures in order to prevent the transmission of infectious organisms and the possibility of exposure from contaminants. This failure to reduce the potential spread of infections by allowing patients and other staff members to be exposed to potential infectious materials and contaminants, placed the welfare and safety of patients and staff at a potential risk of harm. Findings Included: Review on 01/17/2025 of the facility’s policy entitled “General Cleanliness and Infection Guidelines” determined that page 1 stated, “Supplies or patient’s belongings should not be kept or stored behind the machine at the patient station.” 1. On 01/17/2025 at 10:40 a.m., the surveyor observed a box of gloves behind stations #22 and #23 and a blood pressure cuff behind station #13. The Clinical Manager was informed of the findings on 01/17/2025.”

“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: 44367 Based on clinical observations, the facility’s administration failed to ensure that the standards of care related to hand hygiene and glove use requirements were followed by all staff who come in contact with the dialysis patients in the facility. This failure placed the patients and staff at potential risk for nosocomial infections (infections acquired while in a healthcare setting). Staff: #6 and #7 Findings included: According to the Centers for Disease Control and Prevention (CDC), infection can be spread in a dialysis center through the passing of microorganisms from one patient to another by the hands of the caregiver; or if the environmental surfaces are contaminated and touched by a caregiver or patient. Even with glove use, hand hygiene is necessary before gloves are put on and after gloves are removed because hands can become contaminated through small defects in gloves and from the outer surface of the gloves during glove removal. Review on 01/17/2025 of the facility’s policy entitled “Hand Hygiene” determined that page 1 stated, “Hands will be washed with antimicrobial soap and water: When hands are visibly dirt or contaminated with proteinaceous material, blood, or body fluids...” Page 2 also stated that “Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water: Entering and leaving the treatment area...After contact with inanimate objects near the patient...After contact with other objects within the patient station or treatment space.” 1. During observations of the clinical treatment area on 01/17/2025 at 10:25 a.m., Staff #6 entered the clinic treatment area coming from the water treatment room with gloves on. Staff #6 then walked to station #19 and handled the equpiment of the station. With the same gloves in place, Staff #6 then went to occupied station #6 to assist with the television and then left the clinical treatment area. Staff #6 did not remove gloves and performed hand hygiene before, during or after exiting to clinical treatment area. 2. During the treatment discontinuation process at station #13 on 01/17/2025 at 10:54 a.m., Staff #7 had a gross amount of blood on his/her gloves. Staff #7 then walked over to the biohazardous bin and disposed of gloves; however, Staff #7 did not perform hand hygiene. Staff #7 then exited the clinical treatment area through the water treatment room door. The Clinical Manager was informed of the findings on 01/17/2025.”

“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: 44367 Based on clinical observations and review of facility documents, 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: #2 and #9 Findings included: Review on 01/15/2025 of the facility’s policy entitled “Prime Bucket Disinfection” revealed the following excerpt: “Clean all surfaces of the prime bucket or approved receptacle, with 1:100 bleach solution or an approved 1:100 bleach disinfect wipe.” Surveyor observed the following during observations of care: 1. On 01/15/2025 at 11:13 a.m., Staff #2 did not clean the prime bucket during the machine disinfection process at station #2 prior to setting up the machine for the next patient. 2. On 01/16/2025 at 10:48 a.m., Staff #9 did not clean the prime bucket during the machine disinfection process at station #20 prior to setting up the machine for the next patient. The Clinical Manager was informed of the findings on 01/15/2025 and 01/16/2025.”

“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 and discarded medication according to it’s own policy. This failure placed the patients at potential risk. Patent: #11 Findings Included: Review on 01/17/2025 of the facility’s policy entitled “Medication Preparation and Administration” page 3 states, “Medication may be pre-drawn up to 4 hours prior to administration... Any open multi dose vial must be discarded 28 days after opening... “ 1. Inspection of the medication area on 01/17/2025 at 11:17 a.m. revealed, a pre-drawn syringe for Patient #11. the syringe was labeled “600 am” with Patient #11’ name. The medication expired at 10:00 a.m. The medication was not labeled with a date. The Charge Nurse (Staff #2) corroborated that the medication should have been given or discarded at 10:00 a.m. 2. Inspection of the medication area on 01/17/2025 at 11:17 a.m. revealed one vial of Xylocaine 1% was opened and labeled “opened 0700 11/22/24.” The Charge Nurse corroborated that vial should have been discarded 28 days after opening. 3. Inspection of the medication area on 01/17/2025 at 11:17 a.m. revealed one vial of Cefepime 1 gram was open and placed back in the medication cabinet. The Charge Nurse corroborated that the medication should have been used or discarded. The Clinical Manager was informed of the findings on 01/17/2025.”

“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 the facility’s administration, the governing body failed to ensure that the physical structure of the dialysis facility and the water treatment room was kept intact, clean and free from defects at all times. This failure placed the patients, staff, and visitors at potential risk of harm including exposure to hazardous or infectious material from a potentially contaminated water system. Findings included: On 01/15/2025 at 10:30 a.m., during the flash tour of the water treatment room, the surveyor noted the following: · The Mr. Acid (used to transfer acid from the large barrel to the jugs) was covered with a gross amount of white crystallization and some small brown spots. . · Six (6) large barrels of 2.0 K and 2.0 Ca were covered with a gross amount of white and brown colored crystallization. A gross amount of white crystallization was on the floor and around the base of the barrels. · Gross amount of brownish green debris on the floor at the base of the two 2K 2.5 Ca holding tanks. Inspection of the medication area on 01/15/2025 at 11:30 a.m. revealed a broken door on the supply cabinet labeled “4 X 4” above the clean sink. The Clinikcal Manager and the Biomedical technician were informed of the findings on 01/15/2025.”

“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 observations, record reviews, and staff interviews, the facility’s governing body failed to ensure that the facility staff assembled and operated dialysis machines in accordance with manufacturer instructions. The facility also failed to ensure that the dialysis machines were maintenance according to their policy in the event of a Cardiopulmonary Arrest (cardiac arrest). This failure placed patient a risk for harm and potential danger. Staff: #1 and #2 Patient: #10 Machine #8 (4T0S129217) Finding Include: 1. Review on 01/15/2025 of the facility’s policy “Priming an Optiflux Single Use E-Beam Dialyzer” page 5 number 13 revealed the following excerpt, “ Place venous bloodline in the occluding clamp below the air detector and close optical detector door beneath occlusion clamp.” Review on 01/15/2025 at 11:45 a.m. of the Fresenius 2008T Machine Operator’s Manual determined that page 63 stated: “Warning! The tubing beneath the venous drip chamber must be inserted into the venous line clamp and the optical detector.” During observation of the clinical treatment area on 01/15/2025 at 11:38 a.m., the surveyor noted that Staff #2 did not place the venous line in the optical detector prior to initiating the testing of machine #10 at Station #1. At 11:39 a.m. the surveyor informed the Clinical Manager and the Director of Operations of the findings. The Clinical manager and the Director of Operations corroborated that the venous line was not placed in the optical detector during the machine safety testing. At 11:45 a.m., Staff #2 assembled machine #10 correctly and re-tested after receiving instructions from the Director of Operations. On 01/15/2025 at 11:50 a.m., as a result of the surveyor findings the Clinical Manager and the Director of Operations immediately initiated education and training to the entire staff regarding the machine set-up prior testing and during treatment per the manufactures recommendation and the facility’s policy. (Cross-referenced with V0692) 2. Review on 01/17/2025 of the facility’s policy entitled, “Guidelines for Staff Response during Cardiopulmonary Arrest”, determined that page 6 states, “Sequestering of Dialysis Machine: When cardiopulmonary arrest during treatment, the machine will be: Visually inspected for the presence of kinks, twist inappropriately place clamps, tears cuts or leaks in the extracorporeal circuit: Removed machine from the treatment area.: Collect dialysate sample for any concentrates used.: Tag machine and have the machine tested by the Biomedical Staff to ensure proper function (see Device Evaluation Following Patient Event Form.) The machine must pass all aspects of the functional Testing prior to being released for use.” On 01/17/2025, review of the facility’s mortality rate revealed that on 09/02/2024 at 10:08 a.m., Patient #10 experienced cardiac arrest while receiving a dialysis treatment on machine #8. On 01/17/2025, surveyor interviewed the Charge Nurse (Staff #1) who was in the treatment area on 09/02/2024. Staff #1 stated that they were informed by the Biomedical Staff (Bio Med) that machine #8 did not need to be pulled because the “patient did not die.” The Charge Nurse informed the surveyor that they were unaware of the policy quoted above. Interview with Bio Med’s Manager revealed that the machine should have been “pulled from the floor and sequestered.” The Charge Nurse corroborated that Machine #8 was not pulled from the floor after Patient #10 experienced cardiac arrest while receiving dialysis, allowing other patients to receive treatment on Machine #8 without knowing it’s safety status. Review of machine #8’s maintenance and repair history from 01/01/2024 to 12/31/2024 revealed that the machine was not sequestered as a result of Patient #10’s cardiac arrest. There was no evidence of the machine being maintained according to the facility’s policy. The Clinical Manager and the Biomedical Manger were given the opportunity to provide additional documentation; however, no additional documents were provided.”

“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. Patients: #3, #4, #5, #6, #7, and #9 Findings included: Review on 01/16/2025 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 nine (9) selected patients’ medical records on 01/16/2025, the surveyor noted that six (6) out of the nine (9) or 67% 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 missing documentation was as follows: · Patient #3 was admitted to the facility on 08/05/2024. An initial nursing assessment was not found in Patient #3’s the paper or electronic chart. · Patient #4 was admitted to the facility on 10/30/2023. An initial nursing assessment was not found in Patient #4’s the paper or electronic chart. · Patient #5 was admitted to the facility on 12/21/2022. An initial nursing assessment was not found in Patient #5’s the paper or electronic chart. · Patient #6 was admitted to the facility on 06/06/2023. An initial nursing assessment was not found in Patient #6’s the paper or electronic chart. · Patient #7 was admitted to the facility on 03/26/2011. An initial nursing assessment was not found in Patient #7’s the paper or electronic chart. · Patient #9 was admitted to the facility on 08/05/2024. An initial nursing assailment was not found in Patient #9’s the paper or electronic chart. The Clinical Manager was given the opportunity to provide the missing initial nursing assessments; However, the Clinical Manager corroborated that the initial nursing assessments were not completed on the identified patients.”

“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: #4, #6 and #7 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. Review on 01/16/2025 of the facility’s policy entitled “Patient Assessed and Monitoring” page 6 revealed, “check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed flow. Check dialysate flow rate setting in correct, and the prescribed flows is being delivered.” A review of nine (9) selected patients’ treatment flowsheets on 06/13/2024 revealed that three (3) or 33% of the selected patients did not receive the correct dialysis prescription as ordered by the Nephrologist. 1. On treatment date 01/05/2025, Patient #4’s DFR was prescribed for 800 ml/min. However, DFR was set at 700 ml/min for the entire treatment. There was no documentation found explaining why Patient #4’s DFR was not set on the dialysis machine as prescribed. 2. On treatment date 01/14/2025, Patient #6’s BFR was prescribed for 450 ml/min. However, BFR was set at 400 ml/min from 11:30 a.m. to 12:38 p.m. and then from 02:07 p.m. to 03:05 p.m. There was no documentation found explaining why Patient #6’s BFR was not set on the dialysis machine as prescribed. 3. On treatment date 01/14/2025, Patient #7’s BFR was prescribed for 475 ml/min. however, BFR was set at 450 ml/min from 08:04 a.m. to 08:32 a.m. and 425 ml/min from 08:32 p.m. to 09:35 p.m. Patient #7’s DFR was prescribed for 800; however, the DFR was set at 500 ml/min from 08:04 a.m. to 08:31 a.m. and then 600 ml/min from 08:32 a.m. to 09:01 a.m. There was no documentation found explaining why Patient #7’s DFR and BFR were not set on the dialysis machine as prescribed. The Clinical Manager and the Director of Operations were informed of the findings on 01/17/2025.”

“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: 44367 Based on observations and review of the facility’s policies and procedures, the facility’s administration 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: #8 and #10 Findings included: Review on 01/15/2025 of the facility’s policy entitled “Access Assessment and Cannulation” determined that page 2 stated, “Clean your stethoscope with alcohol. Listen: Bruit high pitch/whistle”; and page 4 stated, “Do not touch cannulation sites after skin disinfection.” 1. During observation of the clinical treatment area on 01/15/2025 at 11:15 a.m., during treatment initiation process at station #11, the surveyor noted that Staff #8 did not listened to the patient’s access prior to cannulation. 2. During observation of the clinical treatment area on 01/15/2025 at 11:32 a.m., during treatment initiation process at station #10, the surveyor noted that Staff #8 did not listened to the patient’s access prior to cannulation. 3. During observation of the clinical treatment area on 01/16/2025 at 11:11 a.m., during the treatment initiation process at station #18, the surveyor noted that Staff #10 did not listened to the patient’s access prior to cannulation. The Clinical Manager was informed of the findings on 01/15/2025 and 01/16/2025.”

“PQ-PCT-STATE REQUIREMENTS & HS DIPLOMA CFR(s): 494.140(e)(1),(2) Patient care dialysis technicians must- (1) Meet all applicable State requirements for education, training, credentialing, competency, standards of practice, certification, and licensure in the State in which he or she is employed as a dialysis technician; and (2) Have a high school diploma or equivalency; This Standard is not met as evidenced by: 44367 Based on the review of credentialing records, quality assurance meeting minutes, and patient medical records, the governing body failed to ensure that Technicians who do not possess a Certified Nursing Assistant-Dialysis Technician certification are being supervised when providing care to patients and assembling and operating the dialysis machines in accordance with the manufacturer’s instructions prior to safety testing. This failure placed patient a risk for harm. Staff: #2 and #11 Findings included: Certified Nursing Assistant - Dialysis Technicians (CNA-DT) must meet the requirements of the applicable state for education and training to provide patient care in dialysis facilities, including any state requirements related to practice standards, certification or registration. Review on 01/15/2025 of the facility’s policy “Priming an Optiflux Single Use E-Beam Dialyzer” determined that page 5 number 13 stated, “Place venous bloodline in the occluding clamp below the air detector and close optical detector door beneath occlusion clamp.” Review on 01/15/2025 of the Fresenius 2008T Machine Operator’s Manual, determined that page 63 stated: “Warning! The tubing beneath the venous drip chamber must be inserted into the venous line clamp and the optical detector.” During observation of the clinical treatment area on 01/15/2025 at 11:38 a.m., surveyor noted that Staff #2 did not place the venous line in the optical detector prior to initiating the testing of machine #10 at Station #1. During an interview with the Clinical Manager, it was determined Staff #2 was a new employee and just “passed the exam” and did not have the CNA/DT certification. Staff #2 was scheduled to work under the supervision of the Charge Nurse (Staff #11); however, during observation the surveyor noted that Staff #2 was working independently and the Charge Nurse was on the other side of the unit doing patient assessments. After speaking with the surveyor regarding Staff #2 working independently, the Clinical Manager instructed the Charge Nurse to observe Staff #2 during turnover process (when the first shift of patient are taken off the machine and the second shift of patients are put on the machine). The Clinical Manager and the Director of Operations corroborated that the venous line was not in the optical detector during the machine testing and the Charge Nurse was not supervising Staff #2 during the turnover process. The surveyor noted that from 10:30 a.m. until 11:38 a.m. Staff #2 was turning over patients and was not being supervised by the Charge Nurse. Station #1 was unoccupied and Station #2 was occupied. (Cross Referenced with V0403)”