Fresenius Medical Care of Mashpee

“Multiple Occupancies CFR(s): NFPA 101 Multiple Occupancies - Sections of Ambulatory Health Care Facilities Multiple occupancies shall be in accordance with 6.1.14. Sections of ambulatory health care facilities shall be permitted to be classified as other occupancies, provided they meet both of the following: * The occupancy is not intended to serve ambulatory health care occupants for treatment or customary access. * They are separated from the ambulatory health care occupancy by a 1 hour fire resistance rating. Ambulatory health care facilities shall be separated from other tenants and occupancies and shall meet all of the following: * Walls have not less than 1 hour fire resistance rating and extend from floor slab to roof slab. * Doors are constructed of not less than 1-3/4 inches thick, solid-bonded wood core or equivalent and is equipped with positive latches. * Doors are self-closing and are kept in the closed position, except when in use. * Windows in the barriers are of fixed fire window assemblies per 8.3. Per regulation, ASCs are classified as Ambulatory Health Care Occupancies, regardless of the number of patients served. 20.1.3.2, 21.1.3.3, 20.3.7.1, 21.3.7.1,42 CFR 416.44 This Standard is not met as evidenced by: 16934 This Standard is not met as evidenced by: Based on observations the facility failed to ensure compliance with Section 21.3.7.1. Section 21.3.7.1 states ambulatory health care facilities shall be separated from other tenants and occupancies and shall meet all of the following requirements: (1) Walls shall have not less than a 1-hour fire resistance rating and shall extend from the floor slab below to the floor or roof slab above. (2) Doors shall be constructed of not less than 1-3/4 in. (44 mm) thick, solid-bonded wood core or the equivalent and shall be equipped with positive latches. (3) Doors shall be self-closing and shall be kept in the closed position, except when in use. (4) Any windows in the barriers shall be of fixed fire window assemblies in accordance with Section 8.3. THE FINDINGS INCLUDE: During the afternoon hours of 06/06/24 while viewing the one hour barrier wall separating the facility from the business occupancy, two holes approximately 3” x 3” in size were observed above the ceiling tiles in the wall above the main entrance door. This deficient practice could affect all patients, as well as an undetermined amount of staff in the event of an actual fire emergency where the separation is compromised. As a result, the facility failed to comply with section 21.3.7.1 requiring 1-hour separation. This finding was discussed with and acknowledged by the Clinical Manager and Biomedical Technician II during the exit interview process.”

“Emergency Lighting CFR(s): NFPA 101 Emergency Lighting Emergency lighting of at least 1-1/2 hour duration is provided automatically in accordance with 7.9. 20.2.9.1, 21.2.9.1, 7.9 This Standard is not met as evidenced by: 16934 This Standard is not met as evidenced by: Based on observations, the facility failed to provide emergency lighting in all required locations. Section 21.2.9.1 states emergency lighting shall be provided in accordance with Section 7.9. Section 7.9.2.4 states emergency generators providing power to emergency lighting systems shall be installed, tested, and maintained in accordance with NFPA 110, Standard for Emergency and Standby Power Systems. Stored electrical energy systems, where required in this Code, other than battery systems for emergency luminaires in accordance with 7.9.2.5, shall be installed and tested in accordance with NFPA 111, Standard on Stored Electrical Energy Emergency and Standby Power Systems. NFPA 110 section 7.3.1 states the Level 1 or Level 2 EPS equipment location(s) shall be provided with battery-powered emergency lighting. This requirement shall not apply to units located outdoors in enclosures that do not include walk-in access. Section 7.3.2 states the emergency lighting charging system and the normal service room lighting shall be supplied from the load side of the transfer switch. THE FINDINGS INCLUDE: Observations during the morning hours of 06/06/24 revealed the three rooms containing the automatic transfer switches (ATS’s) are not equipped with battery-powered emergency lighting supplied from the load side of the transfer switch. Interview at the time of observation with the Biomedical Technician confirmed the lack of emergency back up lighting at these three locations. This deficient practice could affect all patients, as well as an undetermined amount of staff in the event of an actual power failure where emergency power is required. As a result, the facility failed to ensure compliance with NFPA 101 and NFPA 110 and the sections referenced above. This finding was discussed with and acknowledged by the Clinical Manager and Biomedical Technician II during the exit interview process.”

“Fire Alarm System - Testing and Maintenance CFR(s): NFPA 101 Fire Alarm Systems - Testing and Maintenance A fire alarm system is tested and maintained in accordance with an approved program complying with the requirements of NFPA 70, National Electric Code, and NFPA 72, National Fire Alarm and Signaling Code. Records of system acceptance, maintenance and testing are readily available. 9.6.1.3, 9.6.1.5, NFPA 70, NFPA 72 This Standard is not met as evidenced by: 16934 This Standard is not met as evidenced by: Based on documentation review the facility failed to ensure that the fire alarm system is tested and maintained as required. Section 21.3.4.1 of the 2012 edition of NFPA 101 Life Safety Code states ambulatory health care facilities shall be provided with fire alarm systems in accordance with Section 9.6, except as modified by 21.3.4.2 through 21.3.4.4. Section 9.6.1.3 states a fire alarm system required for life safety shall be installed, tested, and maintained in accordance with the applicable requirements of NFPA 70, National Electrical Code, and NFPA 72, National Fire Alarm and Signaling Code, unless it is an approved existing installation, which shall be permitted to be continued in use. Section 9.6.1.5 states to ensure operational integrity, the fire alarm system shall have an approved maintenance and testing program complying with the applicable requirements of NFPA 70, National electrical Code, and NFPA 72, National Fire Alarm and Signaling Code. The 2010 edition of NFPA 72 National Fire Alarm and Signaling Code requires that fire alarm system equipment and components be tested and inspected in accordance with the frequencies and methods set forth in Table 14.4.2.2, Table 14.3.1 and Table Table 14.4.5 Section 14.4.5.3.1 states sensitivity shall be checked within 1 year after installation. Section 14.4.5.3.2 states sensitivity shall be checked every alternate year thereafter unless otherwise permitted by compliance with 14.4.5.3.3. Section 14.4.5.3.3 states after the second required calibration test, if sensitivity tests indicate that the device has remained within its listed and marked sensitivity range (or 4 percent obscuration light gray smoke, if not marked), the length of time between calibration tests shall be permitted to be extended to a maximum of 5 years. THE FINDINGS INCLUDE: During the morning hours of 06/06/24 after reviewing the fire alarm system inspection reports dated 03/21/24, 12/19/23, 09/18/23, 05/10/23, and 03/24/23 it was revealed that sensitivity testing of the smoke detectors is not performed as required. The last sensitivity test of the smoke detectors is not known and/or documented on the inspection reports to substantiate the testing has been performed. This deficient practice could affect all patients, as well as an undetermined amount of staff in the event of an actual emergency situation where the fire alarm system is required to be utilized. As a result, the facility failed to comply with the above sections of NFPA 72 requiring the mandatory testing of the automatic fire alarm system per NFPA 72. This finding was discussed with and acknowledged by the Clinical Manager and Biomedical Technician II during the exit interview process.”

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 16934 This Standard is not met as evidenced by: Based on observations and records provided, the facility failed to properly maintain the sprinkler system. Section 21.1.1.1.3 states the provisions of Chapter 4, General, shall apply. Section 4.2.3 states systems utilized to achieve the goals of Section 4.1 shall be effective in mitigating the hazard or condition for which they are being used, shall be reliable, shall be maintained to the level at which they were designed to operate, and shall remain operational. Section 4.5.7 states any fire protection system, building service equipment, feature of protection, or safeguard provided to achieve the goals of this Code shall be designed, installed, and approved in accordance with applicable NFPA standards. Section 4.5.8 states whenever or wherever any device, equipment, system, condition, arrangement, level of protection, or any other feature is required for compliance with the provisions of this Code, such device, equipment, system, condition, arrangement, level of protection, or other feature shall thereafter be maintained, unless the Code exempts such maintenance. NFPA #25 (Standard for Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems) section 4.1.1 states the property owner or designated representative shall be responsible for properly maintaining a water based fire protection system. Section 4.1.1.1.1 states inspection, testing, maintenance, and impairment shall be implemented in accordance with procedures meeting those established in this document and in accordance with the manufacturer’s instructions. Section 4.1.1.2 states inspection, testing, and maintenance shall be performed by personnel who have developed competence through training and experience. Section 4.3.1 states records shall be made for all inspections, tests, and maintenance of the system and its components and shall be made available to the authority having jurisdiction upon request. Section 4.3.2 states records shall indicate the procedure performed (e.g., inspection, test, or maintenance), the organization that performed the work, the results, and the date. Section 4.3.3 states records shall be maintained by the property owner. Section 13.4.1.2 states alarm valves and their associated strainers, filters, and restriction orifices shall be inspected internally every 5 years unless tests indicate a greater frequency is necessary. THE FINDINGS INCLUDE: During the morning hours of 06/06/24 after reviewing the sprinkler system inspection reports dated 03/21/24, 01/31/24, 09/18/23, 05/10/23, and 03/24/23 it was revealed that the last internal examination of the main alarm valve was performed on 09/18/14. The valve was due for re-inspection on 09/18/19. This deficient practice could affect all patients, as well as an undetermined amount of staff in the event of an actual emergency situation where the sprinkler system is required to be utilized. As a result, the facility failed to comply with the above sections of NFPA 25 requiring the mandatory testing of the automatic sprinkler system. This finding was discussed with and acknowledged by the Clinical Manager and Biomedical Technician II during the exit interview process.”

“Fire Drills CFR(s): NFPA 101 Fire Drills Fire drills include the transmission of a fire alarm signal and simulation of emergency fire conditions. Fire drills are held at expected and unexpected times under varying conditions, at least quarterly on each shift The staff is familiar with procedures and is aware that drills are part of established routine. Where drills are conducted between 9:00 PM and 6:00 AM, a coded announcement may be used instead of audible alarms. 21.7.1.4 through 21.7.1.7 This Standard is not met as evidenced by: 16934 This Standard is not met as evidenced by: Based on documentation review and staff interview, the facility failed to comply with NFPA 101 Life Safety Code regulations regarding the conducting of fire drills. Section 21.7.1.4 states fire drills in ambulatory health care facilities shall include the transmission of a fire alarm signal and simulation of emergency fire conditions. Section 21.7.1.5 states patients shall not be required to be moved during drills to safe areas or to the exterior of the building. Section 21.7.1.6 states drills shall be conducted quarterly on each shift to familiarize facility personnel (nurses, interns, maintenance engineers, and administrative staff) with the signals and emergency action required under varied conditions. Section 21.7.1.7 states when drills are conducted between 9:00 p.m. and 6:00 a.m. (2100 hours and 0600 hours), a coded announcement shall be permitted to be used instead of audible alarms. THE FINDINGS INCLUDE: During review of the documentation provided on the morning of 06/06/24, it was observed that actual fire drills in accordance with section 21.7.1.4 are not being performed. The facility is performing an educational type fire drill on a quarterly basis in conjunction with the Emergency Preparedness Procedure tag for orientation and training of facility patients (ID Prefix Tag E40). It was stated by the Clinical Manager that each patient is shown and explained the requirements for E40 along with general information pertaining to fire drills. The patients then sign an acknowledgement the training was received and understood. However, the requirements of ID Prefix Tag E40 differ from the requirements of this ID Prefix Tag K712 and can not be substituted for each other. This deficient practice could affect all patients, as well as an undetermined amount of staff in the event of an actual emergency situation where the fire drill procedures are required to be utilized. As a result, the facility failed to conduct fire drills in accordance with section 21.7.1.4. This finding was discussed with and acknowledged by the Clinical Manager and Biomedical Technician II during the exit interview process.”

“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: 37700 Based on observation, policy review and staff interview, the facility failed to ensure there was a separation of clean and contaminated items in the Peritoneal Dialysis (PD) Training Room. Review of the facility policy, entitled, Cleaning and Disinfecting the Dialysis Station, dated 9/5/23, included the following: *The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station (ex. stethoscope) must be disinfected with 1:100 bleach or Environmental Protection Agency (EPA) registered disinfectant before being removed from the dialysis station. On 5/21/24 at 8:55 A.M., during observation of the PD Training Room, the surveyor observed two sinks. One was labeled, Dirty Sink Area, which had 3 yellow clamps lying near the sink and a blue plastic water bottle lying sideways behind the faucet. The other sink was labeled, Handwashing Sink, which had blue handle scissors, 4 yellow plastic clamps and small rusty metal scissors lying near the sink. During an observation and interview on 5/21/24 at 10:33 A.M., of the PD Training Room with the Home Nurse Program Manager, the Home Nurse Program Manager said the yellow clamps are cleaned and hung on the hooks of the Intravenous (IV) pole located in the room and the clamps and blue water bottle should not have been at the Dirty Sink area. She also said the yellow clamps and blue handle scissors should not have been at the Handwashing Sink area and the rusty scissors should have been discarded.”

“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: 44223 Based on observation, interview, and staff interview, the facility failed to ensure 2 of 2 bleach containers containing 1:100 bleach solution were stored in opaque containers to prevent disintegration of the chemical when exposed to sunlight and air. Findings Include: Review of the policy titled, Cleaning and Disinfection of the Dialysis Station, published 9/5/23, indicated the following: *The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. *Bleach Solutions: Keep bleach solution in a location convenient to all dialysis machines/stations/treatment areas. Bleach solutions will be stored in labeled, covered opaque containers to prevent disintegration of the chemical (Sodium Hypochlorite) when exposed to sunlight and air. The facility failed to ensure 1:100 bleach solution were stored in opaque containers to prevent disintegration of the chemical when exposed to sunlight and air. On 5/21/24 at 9:30 A.M., during the initial tour of the treatment floor, the surveyor observed 2 of 2 bleach containers, containing 1:100 bleach solution, stored in clear non opaque containers on 2 separate windowsills where the sunlight could penetrate through the containers. On 5/22/24 at 9:05 A.M., during an observation of the treatment floor, the surveyor observed 2 of 2 bleach containers, containing 1:100 bleach solution, stored in clear non opaque containers on 2 separate windowsills where the sunlight could penetrate through the containers. During an interview on 5/22/24 at 11:20 A.M., the Clinic Manager acknowledged the bleach containers were on the windowsill and that the containers were clear. She said it made sense why they should not be on the windowsills or in clear containers.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 10249 Based on interview, record review and policy review, the facility failed to ensure staff documented the theoretical conductivity (TCD), which is the expected conductivity of the dialysate calculated by the machine based on the dialysate composition, sodium and bicarbonate settings, prior to initiating treatment for 3 of 5 applicable patients (#2, #4 and #5), out of a total sample of 7 patients. Findings include: Review of the facility’s policy entitled, Checking Conductivity and pH of Final Dialysate, dated 5/6/24, included the following, but not limited to: *The theoretical conductivity (TCD) is calculated by the machine based on the concentrate formula selected, and the sodium bicarbonate values entered in the dialysate composition screen. *Check TCD on all dialysis machines. To ensure delivery of safe dialysate, the conductivity alarm limits must be maintained at +/- 0.5 mS/cm of the TCD. *Record conductivity and pH readings in the treatment record. 1. For Patient #4, the facility failed to ensure staff documented the TCD reading in the medical record for 5 of 9 treatments. Patient #4 was admitted to the facility in March 2024 with a diagnosis of End Stage Renal Disease requiring hemodialysis treatments 3 times a week. Review of 9 treatment sheets, dated 4/29/24 through 5/20/24, indicated that staff failed to document the TCD reading for 5 of 9 treatments including 4/29/24, 5/3/24, 5/6/24, 5/10/24, and 5/20/24. During an interview on 5/22/24 at 10:10 A.M., the Clinic Manager said her expectation is that staff should document the TCD on the treatment sheet prior to each treatment. 2. For Patient #2, the facility failed to ensure staff documented the TCD reading in the medical record for 3 of 9 treatments. Patient #2 was admitted to the facility in October 2020 with a diagnosis of End Stage Renal Disease requiring hemodialysis treatments 3 times a week. Review of 9 treatment sheets, dated 4/26/24 through 5/20/24, indicated that staff failed to document the TCD reading for 3 of 9 treatments including 4/29/24, 5/10/24, and 5/20/24. During an interview on 5/22/24 at 10:10 A.M., the Clinic Manager said her expectation is that staff should document the TCD on the treatment sheet prior to each treatment. Surveyor: Cappuccino, Melissa 44223”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 44223 Based on record review, policy review, and staff interview, the facility failed to complete necessary psychosocial status monitoring for 1 patient (#5) out of a total sample of 7 patients reviewed, by failing to complete standardized mental and physical assessment tool (KDQOL-36) chosen by the Social Worker (SW) within four months of initiating treatment (or first reassessment) and at least annually at regular intervals. Findings Include: Review of the facility policy titled, Measuring Patient Physical and Mental Function, published 4/4/2012, indicated the following: *The purpose of this policy is to provide guidance on using standardized measures to assess patient physical and mental function as mandated in the Conditions for ESRD Facilities. *All members of the interdisciplinary team (IDT) are responsible for addressing identified problem areas that affect optimal patient quality of life as part of the patient’s plan of care. Qualified Social Workers administer the tool, obtain results and share information with the IDT and the patient to address psychosocial issues. *Achieving and sustaining appropriate psychosocial and physical status will be measured by a standardized mental and physical assessment tool: the KDQOL-36 for adults *The KDQOL-36 is administered to patients new to dialysis between the 3rd and 4th month of starting dialysis as part of the patient’s 90-day reassessment and plan of care. *At a minimum, the KDQOL-36 will be administered annually with each patient as part of the annual assessment and plan of care. *When a survey is not completed, the reason for this must be documented in the patient’s medical record in the form of a progress note or Exclusion report printed from the KDQOL-36 application. This note should include the date the survey was presented to the patient and/or parent/guardian and the reason it was not completed. For Patient #5, the facility failed to ensure that the KDQOL-36, had been completed at least annually. Patient #5 was admitted to the facility in November 2021 with a diagnosis of End Stage Renal Disease requiring hemodialysis. Review of the psychosocial progress note, dated 1/29/24 indicated a copy of the KDQOL-36 was given to the Patient for completion. Review of the psychosocial progress noted, dated 2/19/24, indicated the KDQOL-36 had not been returned. The documentation did not include any further information from the SW that the patient was provided with education on the completion of KDQOL-36. Review of the psychosocial progress noted, dated 4/3/24, did not include any documented evidence that the KDQOL-36 had been returned or discussed with Patient #5. Further review of the clinical record failed to indicate any documented evidence Patient #5 had completed the KDQOL-36 or if he/she had refused to complete it. During an interview on 5/22/24 at 11:05 A.M., the SW said she gave Patient #5 the KDQOL-36 assuming he/she would return it since he/she said they still had it. The SW said this was not followed up on and should have been addressed with the patient.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 31240 Based on Quality Assurance Performance Improvement (QAPI) meeting minutes/program review, Kidney Disease Quality of Life survey (KDQOL-36 [rating of symptoms, problems and burdens of kidney disease]) reports, staff interviews, and policy review, the facility’s QAPI Committee failed to analyze data and develop an action plan for the refusal of KDQOL-36 assessments, to help improve psychosocial and physical care. Findings include: Review of the facility’s policy entitled, Quality Assessment and Performance Improvement, dated 5/2/22, included the following: *QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes. *Following a root cause analysis, action plans will be determined and prioritized by the QAPI committee, considering the prevalence and severity of identified problems and by ranking those which have potential to affect patient health and safety as a higher priority than those that do not have such potential. The facility must take immediate and appropriate actions to address any serious threat and ensure patient safety. Review of the facility’s policy entitled, Measuring Patient Physical and Mental Function, dated 4/4/12, included the following: *Patients have the right to refuse to complete the KDQOL-36. However, every effort should be made to ensure that proper education has been provided about how to completion benefits the patient and team in identifying areas of concern to be addressed as part of the patient’s plan of care. *A QAPI process should be initiated to improve rates of completion of the instrument in the facility if there is a high rate of refusal. Review of the facility’s KDQOL-36 Survey Dashboard, dated June 2023 through May 2024, indicated the following relative to refusals: *August 2023 through December 2023- 0% *January 2024- 40% *February 2024- 30% *March 2024- 100% *April 2024- 75% *May 2024- 50% During an interview on 5/22/24 at 11:30 A.M., the Social Worker (SW) said she had met with her manager last week, and they identified an upward trend in KDQOL-34 refusals. She said this information had not been reviewed in QAPI. During an interview on 5/22/24 at 1:00 P.M., after reviewing the data on the KDQOL-36 Survey Dashboard, both the Clinic Manager and the SW said that the upward trend in KDQOL-34 refusals had not been reviewed during recent QAPI meetings, therefore an action plan had not been implemented.”