Rcg Mineola Dialysis

“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: 29191 Based on observation, record review, and interview, the facility staff failed to clean and disinfect contaminated surfaces In-Center Treatment Area, Also, the facility staff failed to follow the “General Cleanliness and Infection Control Guidelines” policy. These findings had the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by allowing supplies to be used that had been exposed to microbial contamination and unclean surfaces. Findings include: During a tour of the facility’s in-center treatment area on 03/03/2025 at 11:00 AM, the following infection control issues were observed: In-Center Treatment Area: * There were 4 sinks in the in-center treatment area. The surveyor observed that 3 of 4 had brown water stains, white crystallized substance, dust, and dirt particles underneath the sink. One of the sinks had an opened cardboard box of “HydroCell Dry Wipes” under the sink. Alongside the box was a dead roach. “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material, serve as generators of and reservoirs for dust.” (AAM1 ST46-Section 5.2 Receiving items).” A review of the policy titled “General Cleanliness and Infection Control Guidelines,” dated July 2024, revealed the following: “PURPOSE: The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. DISINFECTION * All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms and offices. Walkways must be kept clear of debris and free of clutter. * Facilities must adhere to any state-specific regulations that pertain to facility cleaning and disinfection. * Eating, drinking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. * Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present. * Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping. * Facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff. Such cleaning should be done regularly using a schedule developed by the facility. * Supplies or patient’s belongings should not be kept or stored behind the machine at the patient station. * Clean supplies may not be kept under dirty sinks. * Fans may not be used in treatment areas. (ex floor fans, box fans, individual portable fans).” An interview on the afternoon of 03/03/2025 with Staff # 9 acknowledged the infection control issues found during the in-center tour and that staff failed to follow the “General Cleanliness and Infection Control Guidelines” policy.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility failed to monitor and provide the handling of multidose vials. Findings include: During the observation tour on 03/03/2025 at 11:00 AM, the surveyor observed 2 vials of 1% Lidocaine mixed with the box of Heparin. * Two vials of 1% Lidocaine were in the heparin box and one of the vials was found opened and not dated as to when the vial was opened. Once a medication vial is opened the vial is only good for 30 days. There was no way to know how long the vial had been opened. A review of the CDC guidelines revealed the following information: “ a. All multi-dose vials must be dated with a 28-day expiration date after first use, to reflect “the last date that the product is to be used.” b. All multi-dose vials must be initialed at the time of original opening by the person initially accessing the multi-dose vial.” In an interview with Staff #9 on 03/03/2025 at 11:00 AM, it was confirmed the 1% Lidocaine vials were mixed in the box of Heparin and that one of the Lidocaine vials was not dated as to when it was opened.”

“ACID CONC DIST-CONC LABELED & COLOR-CODED RED CFR(s): 494.40(a) 5.5.3 Acid concentrate distribution systems: labeled & color-coded red Acid concentrate delivery piping should be labeled and color-coded red at the point of use (at the jug filling station or the dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. If the acid system remains intact, no rinsing or disinfection is necessary. More than one type of acid concentrate may be delivered, and each line should clearly indicate the type of acid concentrate it contains. This Standard is not met as evidenced by: 48653 Based on observation and staff interview, the facility’s biomedical staff failed to identify and promptly correct an acid leak present in the facility’s water room and in-center treatment area. During a tour of the facility’s water room with Staff # 4 and # 7 on 03/03/2025 at 3:30 PM, the surveyor observed a large acid leak under the acid holding tank. There was a large ring of dried acid crystals around the bottom of the storage tank. The acid was dripping down the holding tank onto the floor. During a tour of the facility’s in-center treatment area with Staff # 4 and # 9 on 03/03/2025 at 3:40 PM, the surveyor observed an acid leak in the chaise wall behind Stations # 13, # 14, # 15, and # 16. There were dried acid crystals along the plumbing and piping inside the chaise wall. An interview was conducted with Staff # 4, # 7, and # 9 on 03/03/2025 at 3:45 PM which confirmed the acid leaks present in the facility’s water room and in-center treatment area.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed to ensure the dialysis facility was maintained in a safe, functional, and comfortable treatment environment for dialysis stations #13 through #14. This deficient practice has the likelihood of causing harm to dialysis patients receiving treatment at the facility due to the unstable chase wall. Findings Include: * Observed behind station #13 were two large cracks in the laminate of the chase wall. If the wall was touched, there was noticeable movement of the wall. The wall itself was very flimsy. Also, there was a yellow glue-like substance running down the seam of the chase wall between station #13 and Station #14. An interview with Staff #4 on 03/03/2025 at 4:30 PM confirmed that the chase wall had 2 large cracks and that the laminate was unstable and flimsy to the touch.”

“PR-PTS INFORMED OF RIGHTS WHEN BEGIN TX CFR(s): 494.70 The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights. This Standard is not met as evidenced by: 48653 Based on record review and staff interview, the facility staff failed to ensure a properly executed informed consent for hemodialysis treatment was completed for 4 (# 3, # 8, # 9, and # 10) of 6 patient medical records reviewed. Also, the facility staff failed to follow the “Informed Consent” and “Patient Rights and Responsibilities” policies. Patient # 3 A review of medical records for Patient # 3 revealed the patient was admitted to the facility on 01/29/2025. The patient’s primary language was identified as “Spanish”. A review of the patient’s “Confirmation of Consent for In-Center Hemodialysis Treatment” revealed the patient received an informed consent printed in English. The form was signed by the patient on 01/30/2025. There was no time, witness signature, or notation of interpretive services rendered to the patient on the informed consent. The facility staff were unable to provide evidence that the consent was obtained prior to the start of the patient’s first dialysis treatment on 01/30/2025 at 1:44 PM because there was no time on the informed consent form. The facility staff were unable to provide evidence that the dialysis therapy, alternatives, and associated risks, benefits, and consequences were explained to the patient by the physician or physician extender, as required in the facility’s “Informed Consent” policy. There was no witness signature on the informed consent form, therefore, it could not be determined if the appropriate clinical personnel, such as a registered nurse, were present and available to reinforce information, answer any questions posed by the patient, or explain other various aspects of the treatment. It could not be determined which, if any, appropriate clinical personnel reviewed the informed consent prior to the patient starting hemodialysis treatment. An interview was conducted with Staff # 10 on 03/04/2025 at 2:30 PM. Staff # 10 confirmed Patient # 3’s primary language was Spanish. Also, Staff # 10 stated, “She understands and speaks very little English, and we often have to use a translator on the iPad”. Patient # 8 A review of medical records for Patient # 8 revealed the patient was admitted to the facility on 02/26/2025. A review of the patient’s “Confirmation of Consent for In-Center Hemodialysis Treatment” revealed the form was signed by the patient on 02/26/2025. There was no time or witness signature on the informed consent form. The facility staff were unable to provide evidence that the consent was obtained prior to the start of the patient’s first dialysis treatment on 02/26/2025 at 1:57 PM because there was no time on the informed consent form. The facility staff were unable to provide evidence that the dialysis therapy, alternatives, and associated risks, benefits, and consequences were explained to the patient by the physician or physician extender, as required in the facility’s “Informed Consent” policy. There was no witness signature on the informed consent form, therefore, it could not be determined if the appropriate clinical personnel, such as a registered nurse, were present and available to reinforce information, answer any questions posed by the patient, or explain other various aspects of the treatment. It could not be determined which, if any, appropriate clinical personnel reviewed the informed consent prior to the patient starting hemodialysis treatment. Patient # 9 A review of medical records for Patient # 9 revealed the patient was admitted to the facility on 02/19/2025. A review of the patient’s “Confirmation of Consent for In-Center Hemodialysis Treatment” revealed the form was signed by the patient on 02/19/2025. There was no witness signature on the informed consent form. The facility staff were unable to provide evidence that the dialysis therapy, alternatives, and associated risks, benefits, and consequences were explained to the patient by the physician or physician extender, as required in the facility’s “Informed Consent” policy. There was no witness signature on the informed consent form, therefore, it could not be determined if the appropriate clinical personnel, such as a registered nurse, were present and available to reinforce information, answer any questions posed by the patient, or explain other various aspects of the treatment. It could not be determined which, if any, appropriate clinical personnel reviewed the informed consent prior to the patient starting hemodialysis treatment. Patient # 10 A review of medical records for Patient # 10 revealed the patient was admitted to the facility on 02/26/2025. A review of the patient’s “Confirmation of Consent for In-Center Hemodialysis Treatment” revealed the form was signed by the patient on 02/26/2025. There was no time or witness signature on the informed consent form. The facility staff were unable to provide evidence that the consent was obtained prior to the start of the patient’s first dialysis treatment on 02/26/2025 at 12:58 PM because there was no time on the informed consent form. The facility staff were unable to provide evidence that the dialysis therapy, alternatives, and associated risks, benefits, and consequences were explained to the patient by the physician or physician extender, as required in the facility’s “Informed Consent” policy. There was no witness signature on the informed consent form, therefore, it could not be determined if the appropriate clinical personnel, such as a registered nurse, were present and available to reinforce information, answer any questions posed by the patient, or explain other various aspects of the treatment. It could not be determined which, if any, appropriate clinical personnel reviewed the informed consent prior to the patient starting hemodialysis treatment. A review of the facility’s policy, “Informed Consent” with a published date of 04/05/2021 revealed the following, “PURPOSE: The purpose of this policy is to ensure each patient or authorized decision maker has authorized to perform designated procedures. RESPONSIBILITY: Nephrologist, physician extended, or licensed nurse (as defined by job description, license, certification, and State and Federal Regulation). Prior to starting dialysis, the patient will have spoken to his or her physician(s), a physician extended, who will have explained dialysis therapy, alternatives, and associated risks, benefits, and consequences. The nurse may reinforce this information while obtaining a signature on the consent and answer any questions raised by the patient. It is inappropriate to have the consent reviewed with the patient by other non-medical personnel such as a social worker or facility clerical staff. Although these persons may explain various aspects of treatment and have expertise in their area of work, the person reviewing the consent requires a broader scope of knowledge ...” A review of the facility’s policy, “Patient Rights and Responsibilities” with a published date of 04/04/2012 revealed the following, “Purpose: To comply with Federal Regulations that require dialysis facilities to: Educate staff regarding the rights of dialysis patients. Inform and educate all dialysis patients about their rights and responsibilities as a patient at the dialysis facility. Ensure that patients’ rights are respected and protected by the facility ... The Conditions for Coverage, §494.70 Condition: Patients’ Rights require dialysis facilities to inform patients or their representatives of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights. Patients’ rights as stated in the Conditions for Coverage: The patient has the right to - 1. Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD; 2. Receive all information in a way that he or she can understand; 3. Privacy and confidentiality in all aspects of treatment; 4. Privacy and confidentiality in personal medical records; 5. Be informed about and participate if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; 6. Be informed about his or her right to execute advance directives, and the facility’s policies regarding advance directives; 7. Be informed about all treatment modalities and settings, including but not limited to transplantation, home dialysis modalities (home hemodialysis, intermittent peritoneal dialysis, continuous ambulatory peritoneal dialysis, continuous cycling peritoneal dialysis), and infacility hemodialysis. The patient has the right to receive resource information for dialysis modalities not offered by the facility, including information about alternative scheduling options for working patients; 8. Be informed of facility policies regarding patient care, including, but not limited to isolation patients; 9. Be informed of facility policies regarding the reuse of dialysis supplies, including hemodialyzers; 10. Be informed by the physician, nurse practitioner, clinical nurse specialist, or physician’s assistant treating the patient for ESRD of his or her own medical status as documented in the patient’s medical record, unless the medical record contains a documented contraindication; 11. Be informed of services available in the facility and charges for services not covered under Medicare; 12. Receive the necessary services outlined in the patient plan of care; 13. Be informed of the rules and expectations of the facility regarding patient conduct and responsibilities; 14. Be informed of the facility’s internal grievance process; 15. Be informed of external grievance mechanisms and processes, including how to contact the ESRD Network and the State survey agency; 16. Be informed of his or her right to file internal grievances or external grievances, without reprisal or denial of services; and 17. Be informed that he or she may file internal grievances or external grievances personally, anonymously or through a representative of the patient’s choosing. 18. Be informed of the facility’s policies for transfer, routine or involuntary discharge, and discontinuation of services to patients; 19. Receive written notice 30 days in advance of an involuntary discharge, if discharge is justified and not due to an immediate threat to the health and safety of others. Policy: All patients and/or their representatives will be informed of their rights (including privacy rights) and responsibilities. Patient rights and the ability to exercise these rights must be protected by the facility. The FMCNA Patient Rights and Responsibilities brochure explains the rights patients can expect to have while receiving treatment at this facility. The brochure also provides guidance as to certain responsibilities that are expected of the patient. Each patient will be informed of their rights and given a copy of the FMCNA Patient Rights and Responsibilities within the first six (6) treatments in the facility. More in-depth discussions with patients about their rights and responsibilities are expected. These discussions may occur over a longer period of time. Facilities should ensure that this information is provided to patients in a manner they can understand. For example, providing the FMCNA Patient Rights and Responsibilities brochure in the patient’s primary language or having it interpreted based on assessment of the patient’s language and reading preferences, or enlisting the aid of communication aids or interpreters for patients who are blind or have low vision, or are deaf or hard of hearing. Dialysis facilities must prominently display a copy of the patient’s rights in a visible and accessible area in the facility and must include contact information for the State survey agency and ESRD Network. The FMCNA Patient Rights and Responsibilities brochures are available in English and Spanish. They may be purchased from the FMS Marketing Online Ordering Center. Audio versions in English and Spanish may also be ordered through the FMS Marketing Online Ordering Center. Patients have the right to privately discuss their condition and treatment. There should be ready access to a room in the facility where patient and/or family meetings may be held in private. Patients have the right to privacy during activities that may require the exposure of private body parts while in the dialysis facility. Privacy screens or curtains may be used to provide privacy. Blankets may also be used as long as staff are able to observe the patient’s vascular access, bloodline connections, and face at all times. Patients or their representatives must be provided unbiased education about transplantation and all dialysis treatment options regardless of whether these options are available in the current facility. Evidence of failure to treat patients with respect and dignity, provide an opportunity for private communication, or prevent exposure of private body areas resulting in emotional discomfort for the patient, and evidence that cognizant patients/designees are not aware of their options for treatment or available grievance mechanisms could result in the facility receiving a Condition level citation. An interview was conducted with Staff # 2 on 03/03/2025 at 2:00 PM, which confirmed the facility staff did not obtain a properly executed informed consent prior to the patient’s treatment starting.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 48653 Based on observation, record review, and interview, it was determined that the facility staff failed to ensure medications maintained in the facility were properly safeguarded and not accessible to unauthorized persons. The facility staff failed to follow the facility policy titled, “MEDICATION POLICY”. Findings include: During a tour of the facility’s in-center treatment area on 12/12/2023 at 9:45 AM with Staff # 9, the surveyor observed unsecured medications at the nurse’s station. The medication drawers were unlocked and there were no licensed personnel safeguarding or supervising the area at the time of the observation. A review of the facility policy titled, “MEDICATION POLICY” with a revision date of October 2022 revealed, “PURPOSE: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. POLICY: 1. The Administrator/designee is responsible for supervising the handling, storing, disposing, administering, and controlling of medications and performs a monthly audit and inventory ... 11. All refrigerated medications, for example, erythropoietin stimulating agents (ESA) and vaccines are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. 23. Medications and needle/syringe storage are done in accordance with state regulations.” An interview with Staff # 2, and # 3 on 12/12/2023 at 11:00 AM confirmed the facility staff did not ensure medications were properly stored and safeguarded from unauthorized personnel.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility staff failed to properly handle and maintain infectious waste within the facility’s in-center treatment area. Findings include: During a tour of the facility’s in-center treatment area on 12/12/2023 at 11:02 AM, the surveyor observed 2 of 2 large biohazard bins soiled with dirt, debris, and other unidentifiable substances on the outside of the bins. 1 of 2 biohazard bins had a large crack in the side of it. The staff failed to properly clean and identify damage to the biohazard bins located within the facility’s in-center treatment area. The biohazard bins being utilized had labels that were damaged and peeling off. The bins were not clearly labeled. Also, there were 4 large biohazard bins stacked and stored in the same area as clean patient equipment. The bins were stored directly next to a patient’s dialysis station where a patient was undergoing treatment. Biohazard bins should always be clearly labeled, sealed, and stored in an area that prevents casual access or contamination. An interview with Staff # 3 and # 9 on 12/12/2023 at 11:15 AM confirmed the presence of biohazard bins improperly stored, labeled, and maintained within the facility’s in-center treatment area.”

“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: 48653 Based on observation and staff interviews, the facility staff failed to demonstrate it followed standard infection control guidelines for the cleaning and disinfection of contaminated surfaces within the dialysis facility. The facility staff failed to properly clean and disinfect equipment used for the care of dialysis patients. Findings include: During a tour of the facility’s in-center treatment area with Staff # 9 on 12/12/2023 at 9:30 AM, the surveyor observed dialysis machines labeled “# 01, # 02, and # 04” with a build-up of white substance on the front, bottom portion of the machines. Also, the surveyor observed 2 of 2 stethoscopes hanging directly above trashcans. The stethoscopes were in close proximity to the trashcans which could result in possible contamination of the stethoscopes. During a tour of the facility’s in-center treatment area with Staff # 3 on 12/12/2023 at 11:00 AM, the surveyor observed Staff # 16 assisting a patient into the dialysis chair using the patient Hoyer lift. After Staff # 16 was done transferring the patient into the dialysis chair, Staff # 16 returned the Hoyer lift to the clean equipment storage area without disinfecting the lift. Staff # 16 did not use any form of disinfectant on the Hoyer lift. An interview with Staff # 3 on 12/12/2023 at 11:15 AM confirmed the facility staff failed to properly clean and disinfect the dialysis machines and the patient Hoyer lift. Staff # 3 also confirmed the presence of stethoscopes hanging directly above trashcans, risking possible contamination.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 48653 Based on observation and staff interview, the facility’s biomedical staff failed to identify an acid leak present within the facility’s water treatment room. During a tour of the facility’s water treatment room on 12/12/2023 at 10:08 AM with Staff # 8, the surveyor observed an acid leak present behind the acid mixer. There was a large amount of white crystal build-up located behind and under the acid mixer. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. During an interview with Staff # 8 on 12/12/2023 at 10:08 AM, Staff # 8 was questioned regarding the acid leak. Staff # 8 stated, “I was not aware there was an acid leak there.” An interview with Staff # 7 and # 8 on 12/12/2023 at 10:30 AM confirmed the facility did not promptly identify and correct an acid leak that was present within the facility’s water treatment room.”

“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: 48653 Based on observation, record review and staff interview, the facility’s biomedical staff failed to ensure 1 of 1 Volumat MC IV (intravenous) pump within the dialysis facility had preventative maintenance (PM) performed according to the manufacturer’s recommendation. Also, the facility’s biomedical staff failed to ensure PM stickers on 3 of 3 oxygen concentrators were clearly labeled and legible. Findings include: During a tour of the facility’s in-center treatment area on 12/12/2023 at 9:50 AM with Staff # 9 (Charge Nurse), the surveyor observed 1 of 1 IV pumps with a PM inspection due date of “08/2023”. Preventative maintenance inspection had not been performed on the machine since 08/2022. During a tour of the facility’s in-center treatment area on 12/12/2023 at 9:50 AM with Staff # 9 (Charge Nurse), the surveyor observed 3 of 3 oxygen concentrators with PM stickers that were not clearly labeled and legible. It was not clear when the PM inspection had been done of the oxygen concentrators. A review of facility policy titled, “Equipment Installation, Operation, Maintenance, Repair, and Disposal” revealed, Purpose: The purpose of this document is to provide instructions for the installation, operation, maintenance, repair, and disposal of equipment. Operation: Unless otherwise directed by company policy and procedures, all equipment will be installed, operated, maintained, and repaired in accordance with manufacturer’s instructions for use (IFU).” An interview with Staff # 3 and # 7 on 12/12/2023 confirmed the IV pump did not have preventative maintenance performed by the PM due date and PM labels were not legible on the oxygen concentrators.”

“LAB-CLIA LABS/MEET NEEDS OF PTS CFR(s): 494.130 The dialysis facility must provide or make available, laboratory services (other than tissue pathology and histocompatibility) to meet the needs of the ESRD patient. Any laboratory services, including tissue pathology and histocompatibility must be furnished by or obtained from, a facility that meets the requirements for laboratory services specified in part 493 of this chapter. This Standard is not met as evidenced by: 48653 Based on observation, record review, and interview, the facility staff failed to properly label patient lab specimens according to the facility policy, “Post Hemodialysis BUN Laboratory Testing”. Findings include: During a tour of the facility’s lab area on 12/12/2023 at 9:48 AM, the surveyor observed 2 of 2 patient blood specimens improperly labeled. The lab specimens were labeled with a handwritten label that only contained the patient’s last name. There was no other patient identifier affixed to the lab specimen and no sticker with a barcode on the lab tubes. A review of the facility document titled, “Post Hemodialysis BUN Laboratory Testing” dated 11/02/2020 revealed the following, “PURPOSE: The purpose of this policy is to provide instruction for obtaining post-hemodialysis blood urea nitrogen (BUN) blood samples, using the slow flow/stop pump technique for patients with an AV access and central venous catheter. POLICY: ... Procedure: 1. Check the tubes are labeled correctly in preparation for shipping ... 5. Place the tubes in a specimen tray and refrigerate until prepared for shipping.” An interview with Staff # 9 on 12/12/2023 at 9:48 AM confirmed the lab tubes were not labeled correctly in preparation for shipping.”