Fmc - Macomb

“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: 50688 Based on observation, document review, and interview for 1 of 8 biohazard sharps containers, the Facility failed to ensure it was removed and replaced prior to becoming full. Findings include: 1. During the observational tour of the treatment area on 12/23/2025 at approximately 10:30 AM, the sharps container on the machine located at dialysis station #5 was noted to have the sharps disposal flap raised upward, with the word “FULL” displayed. The machine, including the outside of the sharps container, was wiped down for disinfection by E#4, between patient machine uses. The sharps container was not removed and replaced with an empty container. 2. On 12/23/2025 at approximately 1:15 PM, the policy titled “General Cleanliness and Infection Control Guidelines” (Published 09/02/2025) was reviewed. The policy stated, “ All containers for storage or disposal of needles/sharps shall be replaced on a regularly scheduled basis or when no more than 2/3 to 3/4 full. The containers must be closed prior to being full (text bolded in policy) and prior to being disposed. 4. On 12/23/2025 at approximately 12:50 PM, an interview was conducted with the Director of Operations (E #1), who indicated the full sharps container should have been removed from the machine and replaced with an empty container.”

“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: 50688 A. Based on observation, document review, and interview the Facility failed to ensure 1 of 2 bleach filled containers, and 1 of 1 bleach bottle used for disinfecting dialysis chairs/machines were covered and mixed daily to ensure appropriate disinfection. Findings include: 1. During the observational tour of the treatment area on 12/23/2025 at approximately 10:30 AM, the following was noted: a. 1 of 2 containers (1 container located near the clean sink) labeled 1:100 (1 part bleach: 100 parts water) did not have the lid securely covering them from approximately 10:30 AM to 11:00 AM. Between the time of 10:30 AM to 11:00 AM, 2 employees, E# 2 and E# 3, used the container labeled 1:100 to soak wipes used for cleaning equipment and dialysis chair without returning the lid to the container. b. 1 of 1 container (located near the dirty sink) labeled 1:10 (1 part bleach: 10 parts water) was dated 12/15/2025 indicating when the bleach solution was mixed. 2. On 12/23/2025, the policy titled “Cleaning and Disinfection the Dialysis Station” (Published 09/02/2025) was reviewed. The policy indicated, “Bleach Solutions: Bleach solutions will be stored in labeled, covered opaque container to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air.” 3. On 12/23/2025, the policy titled “Mixing Bleach” (Published 02/03/2025) was reviewed. The policy indicated, “7. Discard solution daily at end of treatment day or more often if needed.” 4. On 12/23/2025, the policy titled “General Cleanliness and Infection Control Guidelines” (Published 09/02/2025) was reviewed. The policy indicated, “Detergents Germicides and Cleaning Supplies: Approved cleaning solutions shall be prepared daily or more frequently as per policy or manufacturer’s instructions for use. Solutions will be stored and labeled per policy.” 5. On 12/23/2025 at approximately 12:30 PM, an interview was conducted with the Facilities Director of Operations (E #1). E #1 verbally agreed the 1:100 bleach container should have been covered with a lid, securely fastened to prevent evaporation of the solution. E #1 also verbally agreed the 1:10 bleach solution should have been discarded and new solution made daily.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 50688 Based on document review and interview, it was determined for 1 of 6 (E #4) employee personnel file review, the facility failed to ensure that required employee testing and vaccination for Hepatitis B was completed. Findings include: 1. The policy titled “Employee Requirements for Testing and Vaccination for Hepatitis B” (Published 04/05/2021) was reviewed 12/24/2025. The policy states, “Hepatitis B Vaccine Guidelines: Employees will be provided with the vaccine and vaccination at no charge. -The hepatitis B vaccines shall be provided within 10 working days of initial assignment to all employees that have occupational exposure to blood or other potentially infectious materials, unless: the employee has previously received the complete series and antibody testing has revealed that the employee is immune, or the vaccine is contraindicated for medical reasons, or the employee as declined vaccination and signed the declination form.” 2. The employee record for E #4 lacked documentation of employee testing, vaccination, or declination of the Hepatitis B. 3. An interview was conducted with the Director of Operations (E #1) on 12/24/25 at 12:00 PM. E #1 verbally agreed the personnel record for E #4 lacked documentation that testing, vaccination, or declination for Hepatitis B.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 50688 Based on personnel record review, document review and staff interview for 3 of 6 (E #2, E #7 and E #8) personnel files reviewed, the facility failed to ensure annual staff competencies were completed. Findings include: 1. Review of the facility’s Knowledge, Skills and Competency Evaluation for Clinical Staff (Published 06/04/2024) policy states, “Policy: Employees are required to successfully complete all skills requirements, including an initial and annual skills validation, within the given time frame.” 2. Personnel files were reviewed. The personnel files for E #2, E #7 and E #8 lacked annual competencies for 2025. The files indicated the following: a. In E #2’s personnel file, the last recorded competency was dated 12/1/2024. b. In E #7’s personnel file, the last recorded competency was dated 9/16/2024. c. In E #8’s personnel file, the last recorded competency was dated 5/28/2024. 3. In an interview with the Director of Operations, E #1, on 12/24/2025 at approximately 11:00 am, E #1 reviewed the personnel files and verbally agreed E #2, E #7 and E #8’s personnel files lacked the 2025 competencies which should have been completed per policy.”