Macomb Regional Dialysis Center

“IC-SINGLE USE VIALS CFR(s): 494.30(a)(1)(i) Intravenous medication vials labeled for single use, including erythropoietin, should not be punctured more than once. This Standard is not met as evidenced by: 47415 Based on observation, interview, and record review, the facility failed to ensure that 2 of 4 multidose vials observed were dated and initialed upon opening, resulting in the potential for less-than-optimal outcomes to the 18 patients currently receiving treatment at the time of observation. Findings include: On 9/17/24 at 1035, during an observational tour on the treatment floor two multidose vials, (1) Zemplar 10 micrograms (mcg)/2 milliliters (ml) vial and (1) Epogen 20,000 units/2 ml vial were observed in the medication preparation area by station 18. Both vials were on the counter, open, undated, and available for use. On 9/17/24 at 1040, an interview with Staff T was conducted. Staff T was asked if multidose vials should be dated when opened and she stated yes, then proceeded to date and initial the vials at time of the interview. On 9/18/24 review of policy titled, “Infection Prevention and Control Policy”, dated revised 10/2022 revealed, “All multi-dose vials/containers must be labeled with the expiration date when the vial/container is first opened. Multiple dose vials containing a preservative must be discarded within 28 days (excluding Epogen ® which is 21 days, Zemplar® which is 7 days and vaccinations which is the manufacturer’s date on vial) after opening or by the manufacturer’s recommended expiration date, whichever comes first. Refer to policy I 4.8.0 Storage & Preparation of Medications”. On 9/18/24 review of policy titled, “Storage and Preparation of Medication” dated revised 12/1/23 revealed, “All multi-dose vials must be labeled with staff initials and expiration date when the vial is first opened. Multiple dose vials containing a preservative must be discarded within 28 days (excluding Epogen ® which must be discarded within 21 days and Zemplar® multi-dose vial which must be discarded within 7 days) after opening or by the manufacturer’s recommended expiration date, whichever comes first”.”

“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: 15195 Based on observation, interview, and record review, the facility failed to ensure that staff clean and disinfect contaminated surfaces, resulting in the potential to spread infectious agents to the 54 in-center patients treated at the facility on that day. Findings include: On 9/17/24 at approximately 1040, Staff M was observed disinfecting station #16 but did not disinfect the prime waste container prior to next patient use. On 9/17/24 at approximately 1045, Staff M was queried about the prime waste container and s/he stated that s/he did not know about disinfecting the inside of the container. Later, on 9/17/24 at approximately 1530, Staff M was again observed disinfecting station #19 but s/he did not open up the chair wings to disinfect the insides of the chair wings. On 9/17/24 at approximately 1535, Staff M was queried about disinfecting the interior chair sides and s/he stated that s/he couldn’t remember if it was done. 47415 On 9/17/24 at 1020, Staff K was observed cleaning station #2. Staff K failed to drop the dialysis chair side tables and disinfect all surfaces of the side table. On 9/17/24 at 1025, Staff K was queried about cleaning all surfaces of the side table, and stated she was new and unaware that side tables lowered for cleaning between each patient. On 9/17/24 at 1035, Staff L was observed cleaning station #5. Staff L failed to drop the dialysis chair side tables and disinfect all surfaces of the side table. On 9/17/14 at 1040, Staff L was queried about cleaning all surfaces of the side table, and she stated, the tables are lowered at the end of the day for cleaning. On 9/18/24 review of policy titled, “Infection Prevention and Control Policy”, dated revised 10/2022 revealed, “After each patient treatment, after the patient has vacated the station, clean environmental surfaces at the dialysis station, including the bed or chair and countertops, with special attention to external surfaces of the machine and chair, including containers associated with prime waste, using healthcare-grade disinfectant (or minimum 1:100 bleach solution)On . Surfaces must be allowed to air.” On 9/19/24, a more specific policy and procedure for disinfecting the dialysis station was requested and not provided at the time of survey.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 15195 Based on record review and interview, the facility failed to ensure a comprehensive reassessment and revision of the plan of care (POC) was completed monthly for 1 (#5) of 1 unstable in-center hemodialysis patients reviewed, resulting in the potential for unmet patient needs and less than optimal patient outcomes. Findings include: Review of the facility information provided revealed that patient #5 was identified as an unstable patient. Review of patient #5’s medical record revealed that he was an 78-year-old who began in-center dialysis on 11/19/19 but had been recently hospitalized for a hip fracture. The patient’s last plan of care provided was dated 8/1/24 and he was determine to be unstable by the interdisciplinary team. On 9/19/24 at approximately 1015, Charge Nurse A was queried about an updated monthly unstable interdisciplinary (IDT) care plan and she verified that it had not been done. Review of the facility policy titled “Patient Assessment and Care Planning, revised 7/12/24” documented, “A comprehensive IDT assessment of each patient and a revision of the plan of care will be conducted... (2) At least monthly for unstable patients...””

“Hazardous Areas - Enclosure CFR(s): NFPA 101 Hazardous Areas - Enclosure Hazardous areas are protected by a fire barrier having 1-hour fire resistance rating (with 3/4 hour fire rated doors) or an automatic fire extinguishing system in accordance with 8.7.1 or 19.3.5.9. When the approved automatic fire extinguishing system option is used, the areas shall be separated from other spaces by smoke resisting partitions and doors in accordance with 8.4. Doors shall be self-closing or automatic-closing and permitted to have nonrated or field-applied protective plates that do not exceed 48 inches from the bottom of the door. Describe the floor and zone locations of hazardous areas that are deficient in REMARKS. 19.3.2.1, 19.3.5.9 Area Automatic Sprinkler Separation N/A a. Boiler and Fuel-Fired Heater Rooms b. Laundries (larger than 100 square feet) c. Repair, Maintenance, and Paint Shops d. Soiled Linen Rooms (exceeding 64 gallons) e. Trash Collection Rooms (exceeding 64 gallons) f. Combustible Storage Rooms/Spaces (over 50 square feet) g. Laboratories (if classified as Severe Hazard - see K322) This Standard is not met as evidenced by: 36613 Based on observation and interview, the facility failed to provide self-closing or automatic closing devices on Hazardous areas in accordance with 8.7.1 or 21.3.2. This deficient practice could affect 10 occupants in the event of fire. Findings Include: On September 17, 2024 at approximately 12:00 PM, observation revealed the facility created a storage space in the room adjacent to the physicians office. The room is sprinklered and contains combustible items in storage, however, the door does not have a self-closing or automatic closing device installed. These findings were confirmed through interview with the facility technical lead at the time of observation.”

“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: 36613 Based on observation and interview, the facility failed to ensure the automatic sprinkler and standpipe systems are inspected, tested and maintained in accordance with NFPA 25, and records are readily available as required by 9.7.5, 9.7.7, 9.7.8 and NFPA 25.5.2.1.1. This deficient practice could affect all occupants in the event of a fire. Findings Include: On September 17, 2024 at approximately 10:15 AM, observation revealed the sprinkler head located in the conference room is damaged. The deflector plate is bent. This will not allow the wet sprinkler to function as designed when needed during a fire. These findings were confirmed through interview with the facility technical lead at the time of observation.”

“Maintenance, Inspection & Testing - Doors CFR(s): Maintenance, Inspection & Testing - Doors Fire doors assemblies are inspected and tested annually in accordance with NFPA 80, Standard for Fire Doors and Other Opening Protectives. Non-rated doors, including corridor doors to patient rooms and smoke barrier doors, are routinely inspected as part of the facility maintenance program. Individuals performing the door inspections and testing possess knowledge, training or experience that demonstrates ability. Written records of inspection and testing are maintained and are available for review. 19.7.6, 8.3.3.1 (LSC) 5.2, 5.2.3 (2010 NFPA 80) This Standard is not met as evidenced by: 36613 Based on observation and interview, the facility failed to maintain fire rated doors, potentially allowing smoke to escape the rated space and enter the emergency egress corridor. This deficient practice could affect all occupants in the event of an evacuation through the main corridor. Findings Include: On September 17, 2024, at approximately 12:30 PM, observation revealed the rated double fire door to the main supply room on the corridor delivery side has a gap in excess of 1/8 inch. This will allow smoke to escape the rated space and enter the emergency egress corridor. These findings were confirmed through interview with the technical lead at the time of observation.”

“Electrical Systems - Essential Electric Syste CFR(s): NFPA 101 Electrical Systems - Essential Electric System Alarm Annunciator A remote annunciator that is storage battery powered is provided to operate outside of the generating room in a location readily observed by operating personnel. The annunciator is hard-wired to indicate alarm conditions of the emergency power source. A centralized computer system (e.g., building information system) is not to be substituted for the alarm annunciator. 6.4.1.1.17, 6.4.1.1.17.5 (NFPA 99) This Standard is not met as evidenced by: 36613 Based on observation and interview, the facility failed to ensure the remote annunciator is in a location readily observed by operating personnel, as required by 6.4.1.1.17, 6.4.1.1.17.5, NFPA 99. This deficient practice could affect all occupants in the event the emergency generator fails during power loss. Findings Include: On September 17, 2024 at approximately 1:40 PM, observation revealed the emergency generator annunciator is located on the 1st floor electrical room. The 1st floor electrical room is a secured room without operating personnel in the room. This may lead to the facility emergency generator annunciator to go into an alarm state and the alarm not being received by staff leading to the generator not function when needed during a power loss. These findings were confirmed through interview with the technical leader at the time of observation.”