Davita Windsor Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 47759 Based on the overall findings of this survey, it was determined that the facility’s governing body and medical director failed to ensure that all staff members were in compliance with the established written protocols for cleaning and disinfecting dialysis machine equipment. This was a repeat deficiency from a recertification survey conducted in 2021. This recurring failure placed patients at potential risk for harm due to possible exposure to blood-borne pathogens and chemical residuals and resulted in a finding that the facility was out of compliance with the Condition for Coverage: Infection Control. Findings Included: Cross Reference: Infection Control - Disinfect surfaces/equipment/written protocols (V0122).”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 47759 Based on the overall findings of this survey, it was determined that the facility’s governing body and medical director demonstrated deficient practices in their oversight of the water system, as evidenced by staff non-compliance with multiple standards/policies related to water treatment and dialysate preparation equipment accessibility and maintenance, mixing system procedures and maintenance, and dialysate proportioning procedures. These pervasive failures placed the facility patients at potential risk of harm and resulted in a finding of the facility being out of compliance with the Condition for Coverage: Water & Dialysate Quality. Findings Included: 1. The facility’s governing body and the medical director failed to ensure that the water room remained secured and restricted from unauthorized access. Cross Reference: Acid conc mix sys-empty all/prev corrosion (V0184). 2. The facility’s governing body and the medical director failed to ensure that all components of the water system were easily accessible. Cross Reference: Environment-access to ports/meters (V0185). 3. The facility’s governing body and the medical director failed to ensure that disinfection of the water distribution system occurred on a monthly basis. Cross Reference: Bacterial control-disinfect 1X/month (V0219). 4. The facility’s governing body and the medical director failed to ensure that all staff members were in compliance with the acid mixing systems procedure. Cross Reference: Mixing systems-perm record/verif test (V0229). 5. The facility’s governing body and the medical director failed to ensure that all staff members took adequate measures in order to maintain the mixing system clean and free of spills of concentrate to reduce the potential of corrosion. Cross Reference: Acid conc mix sys-empty all//prev corrosion (V0231). 6. The facility’s governing body and the medical director failed to ensure that 1.) pH was performed before starting the treatment of each patient, 2.) pH testing was performed according to the direction for use, and 3.) staff members demonstrated knowledge of the acceptable range for the final dialysate pH result. Cross Reference: Dialysate proportion-monitor pH/conductivity (V0250).”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 47759 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 provide a safe and functional environment of care; and 2) failure to ensure that all the dialysis machines used for patient care were operated in accordance with manufacturer’s instructions. This failure placed all patients at increased risk for harm. Findings Included: 1. The facility’s governing body and the medical director failed to provide dialysis patients, staff, and the public with a a safe, functional, and comfortable treatment environment. Cross Reference: Physical Environment-Building-Constructed and maintained for safety (V0402). 2. The facility’s governing body and the medical director failed to ensure that the facility staff operated dialysis machines in accordance with the manufacturer’s recommendations. Cross Reference: Physical Environment-Equipment Maintenance-Manufacturer’s DFU (V0403).”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 47759 Based on record review and a staff interview, the facility’s governing body failed to: 1) document a community based emergency training exercise conducted; and 2) analyze the facility’s response to the facility based emergency training exercise conducted. This failure placed the patients and staff at potential risk of harm in case of an emergency. Findings Included: On 02/03/2025 from 11:00 a.m. -12:00 p.m., review of the facility’s policy titled “Facility Emergency Management Plan (EMP)” (04-07-01) determined that page 27 under EMP training exercises stated, “The facility will conduct and/or participate in one (1) exercise to test the facility’s EMP at least annually, conducted on opposite years (one year full-scale exercise, next year facility based/exercise of choice).” Page 28 stated, “ ... document: c. evaluation of the plan. d. plan revisions required.” On 01/31/2025 at 11:30 a.m., record review of the Facility and Community Emergency Preparedness/Emergency Management Plan binder revealed the following: 1. No documentation for 2024-2025 community emergency preparedness training records could be presented to the surveyor. 2. The facility based emergency preparedness training completed in 2024 did not have a complete evaluation form. During an interview, the Facility Administrator stated that, moving forward, he/she will make sure that the evaluation form will be completed.”

“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: 47759 Based on staff interviews and record reviews, the facility’s governing body failed to ensure that all staff members were in compliance with the established written protocols for cleaning and disinfecting dialysis machine equipment. This failure placed patients at potential risk for harm due to possible exposure to blood-borne pathogens and chemical residuals. This was a repeat deficiency from a recertification survey conducted in 2021. Findings included: On 02/03/2025 from 11:00 a.m. -12:00 p.m., review of the facility’s policy titled “Fresenius Dialysis Delivery System Cleaning and Disinfection Policy” (Policy 1-15-01) determined that page 2 number 7 stated, “at a minimum the facility specific log must include the following elements: ...Post chemical rinse residual test, verification of negative chemical residual test just prior to next use.” Number 11 stated: “Teammates will perform a second chemical residual test on each dialysis delivery system that was chemically disinfected prior to the start of dialyzer set up and record on the facility ’ s Dialysis Delivery System Cleaning and Disinfection Log.” On 01/30/2025, interviews with Staff #8 revealed that the facility’s “bleach day” occurs on Tuesdays. Per policy, staff members should be performing an initial residual test upon completion of the bleach treatment and a secondary residual test verification the next treatment day right before patient treatment. On 01/30/2025 between 12:00 p.m. -01:00 p.m., review of the Fresenius Dialysis Delivery System Clean and Disinfect Log from 10/14/2024 through 01/29/2024 revealed the following: 1. On the following dates: 10/15/2024, 10/22/2024, 10/29/2024, 11/05/2024, and 11/12/2024, 11/19/2024, and 11/26/2024, the surveyor observed that there was no documentation of initial and secondary residual checks recorded after performance of bleach procedure. 2. On the following dates: 12/3/2024, 12/10/2024 12/23/2024, 12/31/2024, 01/07/2024, 01/14/2024, 01/21/2024, the surveyor observed that the documentation for residual check was inaccurate and did not follow the instructions on the documentation. a. According to Staff #8, Staff members should be: i. Following the legend provided as a guide. For example, instead of documenting the character (-), the staff members should be writing down “N” for negative. ii. Following the instructions that stated: “Circle the appropriate daily cleaning and disinfect process performed,” instead of placing a diagonal line on the form. iii. Following the prompt and place the staff members initials where indicated and the residuals result where indicated. Staff members should not be placing the result of the residuals where the staff members initials are indicated. 3. Review of the prior recertification survey report written on 06/2021 revealed that this deficiency is a repeat finding.”

“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: 47759 Based on record reviews and a staff interview, the facility’s governing body failed to ensure that all susceptible patients were offered Hepatitis B Vaccination. This failure placed the affected susceptible patients at potential risk of exposure to blood borne pathogens with a risk for seroconversion. Findings Included: On 02/03/2025 from 11:00 a.m. -12:00 p.m., review of the facility’s policy titled “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” (Policy 1-05-02) determined that page 2 stated that patients deemed susceptible with a Hepatitis B Surface Antigen (HBsAg) of less than 10 will be offered vaccination series. Page 3 number 10 stated: “The patient will consent to the vaccination or will decline. The completed form will be kept in the patient’s health record.” On 01/31/2025 at 12:00 p.m., during record review of the facility’s “Vaccination and Surveillance Report,” the surveyor observed that 2 out of the 8 (25%) selected patients audited had “no current hepatitis B vaccination documented.” On 01/31/2025, the surveyor requested for the vaccination consent or declination form for the 2 susceptible patients (Patients C and G). No consent or declination form for Hepatitis B Vaccine could be presented by the Manager of Clinical Services (MCS).”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, and review of the facility policies and procedure, the facility’s governing body failed to ensure that the water room remained secured and restricted from unauthorized access. This failure placed the quality of the water supply at potential risk of tampering, thereby placing patients at potential risk of harm. Findings Included: On 02/03/2025, from 11:00 a.m. -12:00 p.m., during review of the facility ’ s policy titled “Physical Environment” (Policy 8-04-01), page 2 number 9 stated: “Access to patient treatment areas, water treatment systems, supply storage and dialysis equipment is restricted to authorized personnel only.” On 01/30/2025 at 08:52 a.m., the surveyor observed an external personnel alone in the water room area. The Facility Administrator was immediately informed of the finding, and he/she immediately sent the administrative assistant to accompany and monitor the external personnel while on the premises. During an interview with the Facility Administrator, he/she stated that external personnel in the facility should always be accompanied by a facility staff member if entering a restricted area.”

“ENVIRONMENT-ACCESS TO PORTS/METERS CFR(s): 494.40(a) 8 Environment: access to ports/meters The layout of the water purification system should provide easy access to all components of the system, including all meters, gauges, and sampling ports used for monitoring system performance. This Standard is not met as evidenced by: 47759 Based on observations and a staff interview, the facility’s governing body failed to ensure easy access to all components of the water system. This failure limited staff’s ability to access components necessary for equipment monitoring and placed the water system at risk for possible damage. Findings Included: According to the American National Standards Institute (ANSI/AAMI RD52:2004), the layout of the water purification system should provide easy access to all components of the system. On 01/30/2025 between 12:00 p.m. -01:00 p.m., during observations of the water room, the surveyor observed several boxes of Dry Acid Concentrates adjacent to the Dry Acid Dissolution Unit (DADU). Interviews with Staff #8 revealed that the boxes impeded with Staff #8 ’ s ability to access the DADU ’ s posterior portion.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 47759 Based on record reviews and staff interviews, the facility’s governing body failed to ensure: 1) that disinfection of the water distribution system occurred at least monthly; and 2) that staff members documented according to policy. This failure placed the water system at risk of failing and placed patients at risk of potential harm. Findings Included: On 02/03/2025 from 11:00 a.m. -12:00 p.m., review of the facility’s policy titled “Water Treatment System Disinfection” (Policy 1-16-01) determined that page 1 number 5 stated: “Chemically-disinfected indirect feed systems are disinfected monthly.” Additionally, page 3 number 15 stated, “Facility teammates are to perform independent residual chemical tests prior to the beginning of the daily activities on the first treatment day following a water treatment system or membrane chemical disinfection at all locations.” On 01/30/2025 between 12:00 p.m.-01:00 p.m., during review of the “Titan Water System Disinfection Log” and “Titan Minncare HD Testing Documentation”, the surveyor observed the following: 1. No documentation of disinfection of the water distribution system could be presented to the surveyor for the months of October 2024 and November 2024. 2. Review of the “Titan Minncare HD Testing Documentation” log revealed incomplete and/or inaccurate documentation of the date the tests were performed. a. According to the logs dated 01/2024, 02/2024, 03/2024, and 12/2024, the date the disinfection occurred and the date facility teammates performed independent residual chemical tests were the same which according to Staff #9 was not accurate as staff members checked the residuals the day after disinfection day, prior to patient treatment per policy. b. According to the logs dated 05/2024 and 07/2024, it was unclear when the Minncare hemodialysis negative residual testing was performed due to the lack of recorded date on the document provided.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 47759 Based on record review, staff interviews, and observations, the facility’s governing body failed to ensure staff compliance in completing mixing log documentation. This failure placed patients at risk of potential harm. Findings Included: On 02/03/2025 from 11:00 a.m. -12:00 p.m., review of the facility’s procedure titled “Granuflo Concentrate Dissolution Unit (132 Gallon) Mixing Procedure” (Procedure 1-20-04 A) determined the following: a. Page 3 number 7 column 1 stated, “Operator and Licensed Nurse must compare Catalog Number on Granuflo boxes to verify they are the same and then document on the Granuflo Batch Production Record where indicated.” b. Page 7 number 21 column 1 stated, “Document the hydrometer and temperature reading on the Granuflo Batch Production Record where indicated. Be certain that the Licensed Nurse has observed both of the tests, documentation of tests result and the specific gravity acceptable limits. After completing documentation 22. of the hydrometer and temperature reading, both the Operator and Licensed Nurse must sign the Granuflo Batch Production Record where indicated.” c. Page 7 number 22 column 2 stated, “By signing the Batch Production Record, both the Operator and Licensed Nurse acknowledge that hydrometer check was properly performed and documented.” d. Page 8 number 3 column 1 stated, “Operator and Licensed Nurse must compare Catalog Number on Batch Record and Mixer Label to Catalog Number on Acid Concentrate Storage tank to be filled; this will verify they are the same and then document on the Granuflo Batch Production Record.” On 01/30/2025 between 12:00 p.m. -01:00 p.m., surveyor review of the “Granuflo (132 Gallon) Batch Production Record” from 11/20/2024-01/29/2024 revealed that, on 11/20/2024 and 12/29/2024, there was no Licensed Nurse signature verifying the information documented. According to Staff #8, Licensed Nurses should have signed on the document attesting that they had verified the procedure and the tests performed by the operator.”

“ACID CONC MIX SYS-EMPTY ALL/PREV CORROSION CFR(s): 494.40(a) 5.4.4.2 Acid concentrate mixing systems: empty completely/prevent corrosion Acid concentrate mixing tanks should be designed to allow the inside of the tank to be completely emptied and rinsed according to the manufacturer’s instructions when concentrate formulas are changed. Acid concentrate mixing tanks should be emptied completely before mixing another batch of concentrate. Because concentrate solutions are highly corrosive, mixing systems should be designed and maintained to prevent corrosion. This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, and record review, the facility’s governing body failed to ensure that the clinical staff took adequate measures in order to maintain the mixing system clean and free of spills of concentrate to reduce the potential of corrosion. This failure placed the water system at risk for failing and patients at risk for harm. Findings Included: On 02/03/2025 from 11:00 a.m. -12:00 p.m., during record review of the Granuflo Dissolution Unit Manufacturer’s direction for use, the surveyor noted that page 32 of the document stated, “Clean the exterior surface of the Dry Acid Dissolution Unit (DADU) thoroughly after each batch of concentrate is mixed.” On 01/28/2025 at 08:45 a.m., during inspection of the water room, the surveyor observed white residuals surrounding the Granuflo/Dry Acid Dissolution Unit . On 01/30/2025 at 12:00 p.m., during an interview with Staff #8, the staff stated that staff members did not consistently clean the DADU after usage.”

“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: 47759 Based on observations, record review, and staff interview, the facility’s governing body failed to ensure that: 1) pH testing was performed before starting the treatment of each patient; 2) pH testing was performed according to the direction for use; and 3) staff members demonstrated knowledge of the acceptable range for the final dialysate pH result. This failure placed the affected patients at potential risk of harm. Findings Included: 1. On 01/29/2025, during review of the facility’s policy titled “Testing pH and conductivity of proportioned dialysate and verification of temperature of proportioned dialysate,” page 1 number 6 stated: “Independent pH is required to be performed prior to each treatment.” a. Page 1 of “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” (Policy 1-03-02) stated: “Independent pH is required to be performed prior to each treatment ...The acceptable range for final dialysate pH is 6.9-7.6. Check independent pH with approved test method for final dialysate ... .If independent result is not within acceptable range, retest. If the result is still outside acceptable range, do not use the delivery system for patient treatment. b. E-Z Check Test Strip instructions for use stated: “Compare test results to color scale on bottle between 5 and 10 seconds. Retest if the results are not read within the 10 second time frame.” 2. On 01/29/2025 at 09:55 a.m., during pre-treatment set up, the surveyor observed Staff #5, who was in orientation with Staff #1, connect the dialysate supply line to the Hansens without checking the pH first. The surveyor asked Staff #5 what the pH was for the machine to verify finding. Staff #5 could not tell the surveyor the pH. Staff #1 took over the pH testing procedure and the surveyor did not observe Staff #1 physically compare the test strip result to the color scale on the pH strip bottle. The surveyor informed Staff #4 of the finding, and Staff #4 immediately intervened and retested the pH level. At 10:20 a.m., during an interview, Staff #1 stated that moving forward, he/she will take the pH strip bottle and the pH strip and compare the colors directly. From 10:25 a.m. -10:35 a.m., interviews with various staff members revealed that 2 out of the 5 staff members interviewed were not able to verbalize the correct pH range: a) According to Staff #6, the pH range should range between 6.8-7.8 b) According to Staff #7, the pH range should range between 6.8-7.6 The facility provided an in-service education for all staff between 01/29/25 and 01/30/25 related to the observed deficient practice.”

“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: 47759 Based on observations, staff interviews, and record reviews, the facility’s governing body failed to provide dialysis patients, staff, and the public with a safe, functional, and comfortable treatment environment. This failure placed the patients, staff and visitors at potential risk of harm, including injury or infection. Findings Included: On 02/03/2025, from 11:00 a.m. -12:00 p.m., review of the facility’s policy titled “Physical Environment” (Policy 08-04-01) determined that page 1 number 1 stated: “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment.” On 01/28/2025 at 09:00 a.m., during observations of the facility’s physical environment, the surveyor observed the following: 1. Open access to the laboratory area where hazardous items can be found. a. On 01/30/2025, during an interview, Staff #8 stated that the exposed laboratory area posed an infection control as well as a privacy concern to patients. 2. Nonfunctional door lock separating the treatment floor from the water room located at the back corner of the treatment floor. a. On 01/30/2025, during an interview, the Facility Administrator stated that the lack of a functioning lock to the water room posed concerns for tampering with the water system. 3. Lack of accessible entry door from the entrance hallway to the treatment floor.”

“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: 47759 Based on observations, record reviews, and staff interviews, the facility’s governing body failed to ensure that the facility staff operated dialysis machines in accordance with the manufacturer’s recommendations. This failure placed the affected patients at potential risk of serious injury and serious harm. Patient A Staff #1, #3, #4, #5, #6, and #7 Findings Included: 1. On 01/28/2025 and 01/29/2025, during review of the facility’s policies and machine manual, the surveyor observed the following: a. 2008T Machine Operator’s Manual page 205 numbers 1-2 stated, troubleshoot the machine first and then number 3 stated “press the reset key to reset the alarm. If unable to reset alarm, return the blood to the patient and take the machine out of service. b. “Hemodialysis Delivery System Safety Condition Required During Treatment” (Policy 1-15-10) page 1 number 1 stated “The detector will remain armed at all times during treatments. The only exception is when the alarm is being reset. When resetting the alarm, the blood pump will be turned off and the venous blood line clamped prior to opening the alarm latch.” c. 2008T Machine Operator’s Manual page 19 under general warnings, it stated, “Improper functioning of the level detector may be caused by a clot of blood.” d. 2008T Machine Operator’s Manual page 172 stated, “Carefully observe the arterial bloodline for presence of air. Be sure no air will be infused into the patient.” e. “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate.” (Policy 1-03-02) page 1 stated “Independent pH is required to be performed prior to each treatment ...The acceptable range for final dialysate pH is 6.9-7.6. Check independent pH with approved test method for final dialysate ... .If independent result is not within acceptable range, retest. If the result is still outside acceptable range, do not use the delivery system for patient treatment. f. E-Z Check Test Strip instructions for use stated “Compare test results to color scale on bottle between 5 and 10 seconds. Retest if the results are not read within the 10 second time frame.” g. “Priming a Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Nipro or Combiset Blood Lines for Subsequent Treatment Shifts.” (Policy 1-03-06W) page 8 numbers 32 stated to “Check Independent pH.” Number 34 stated, “Open shunt door and attach dialysate lines to dialyzer verifying that the red colored Hansen is connected to the arterial end of the dialyzer and the blue colored Hansen is connected to the venous end of the dialyzer. Close the shunt door. 2. On 01/28/2025 at 10:24 a.m., during patient A’s treatment, the surveyor observed Station #6 Machine #7 alarm stating “Air detector alarm.” The surveyor observed Staff #3 reset the alarm multiple times. According to Staff #3, he/she had reset the alarm five times. The surveyor immediately informed Staff #4 of the finding, and Staff #4 immediately took the patient off the machine and began troubleshooting the machine. After troubleshooting the machine, Staff #4 concluded that machine #7 needed to be pulled out of the treatment floor due to malfunctioning air detector alarm. Staff #4 then instructed Staff #1 to return the blood back to the patient and pull the machine out of service. a. At 10:33 a.m., Staff #1 was observed: 1) returning Patient A’s blood without the optical detector door armed; and 2) not carefully monitoring the arterial bloodline as Staff #1 was observed to attend to Station #5’s machine alarm as well as repeatedly turning around to throw surrounding trash around Station #6 to the trash can behind him/her. The surveyor immediately informed Staff #4 of the finding and Staff #4 immediately intervened. b. At 10:38 a.m., during an interview, Staff #4 stated that Staff #1 should not have stepped away from the station and should have paid close attention to the patient’s line. c. At 10:40 a.m., during an interview, Staff #1 stated that he/she should have paid more attention to the machine and the patient’s line during blood return. d. The facility provided immediate re-education of the involved staff members and in-service education for all staff between 01/28/25 and 01/30/25 related to the observed deficient practices. 3. On 01/29/2025 at 09:55 a.m., during pre-treatment set up, the surveyor observed Staff #5, who was in orientation with Staff #1, connect the dialysate supply line to the Hansens in preparation of initiating treatment without checking the pH first. The surveyor asked Staff #5 what the pH was for the machine to verify finding. Staff #5 could not tell the surveyor the pH. Staff #1 took over the pH testing procedure and the surveyor did not observe Staff #1 physically compare the test strip result to the color scale on the pH strip bottle. The Surveyor informed Staff #4, and Staff #4 immediately intervened and retested the pH level. a. At 10:20 a.m., during an interview, Staff #1 stated that moving forward, he/she will take the pH strip bottle and the pH strip and compare the colors directly. b. From 10:25 a.m. -10:35 a.m., 2 out of the 5 staff members interviewed were not able to verbalize the correct pH range. i. According to Staff #6, the pH range should range between 6.8-7.8 ii. According to Staff #7, the pH range should range between 6.8-7.6 The facility provided an in-service education for all staff between 01/29/25 and 01/30/25 related to the observed deficient practice.”

“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: 47759 Based on observations, record review, and staff interviews, the facility ’ s governing body failed to conduct and/or obtain a copy of Patient C ’ s history and physical. This failure denied Patient C individualized care. Findings Included: On 02/03/2025 from 11:00 a.m. -12:00 p.m., during review of the facility ’ s policy titled “Accepting End Stage Kidney Disease Patients for Treatment” (Policy 3-01-03), page 4 number 4b stated that, prior to admission, facility must obtain a “Copy of history and physical (within the last year - must be legible).” According to the National Institutes of Health, “The medical history can reveal diagnosed medical conditions, past medical conditions, and potential future health risks for the patient ...The primary goal of obtaining a medical history from the patient is to understand the patient’s state of health and determine whether the history is related. The secondary goal is to gather information to prevent potential harm to the patient during treatment.” On 01/30/2025 at 11:30 a.m., review of Patient C ’ s medical records revealed that there was no information gathered disclosing Patient C ’ s History and Physical (H&P). During an interview, the Manager of Clinical Services stated that H&P should have been obtained prior to the patient’s admission.”

“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: 47759 Based on record review, observations, and staff interviews, the facility’s governing body failed to ensure that the dialysis treatment provided to patients was in accordance with the written prescription. This failure placed the affected patients at potential risk of harm and denied patients their rights to a minimum standard of medical care. Findings Included: According to the National Kidney Foundation, the ultrafiltration rate (UFR) is the rate set on the dialysis machine for removing excessive fluid from a dialysis patient. On 02/03/2025 from 11:00 a.m. -12:00 p.m., review of the facility’s policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” (Policy 1-03-08) determined that page 2 stated, “The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: ...c. Target Weight ...d. Ultrafiltration Rate (UFR) and Maximum UFR ...f. Blood flow rate ... g. Dialysate flow rate” Page 4 number 10 stated, “If the dialysis prescription is not being met, the reason will be documented and the licensed nurse informed. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record.” Page 5 under fluid status stated, “Removal goal not to exceed maximum ordered by physician” On 01/31/2025 at 01:00 p.m., review of the selected patients’ treatment flowsheet revealed the following: 1. On treatment dates 01/23/2025, 01/25/2025, and 01/28/2025, Patient F did not achieve the prescribed target weight. On 01/23/2025, Patient F was 1.5 kg over the target weight. On 01/25/2025, Patient F was 1.5 kg over the target weight. On 01/28/2025, Patient F was 2.8 kg over the target weight. No supporting documentation of acknowledgement, education, and/or provider notification was observed. 2. On treatment date 01/25/2025 and 01/28/2025, Patient B did not achieve the prescribed target weight. On 01/25/2025, Patient B was 2.3 kg over the target weight. On 01/28/2025, Patient B was 1.6 kg over the target weight. No supporting documentation of acknowledgement, education, and/or provider notification was observed. 3. On treatment date 01/28/2025, Patient H ’ s prescribed maximum UFR was 13 mL/kg/hr. Review of Patient H ’ s UFR on treatment date 01/28/2025 revealed an actual UFR of 16 mL/kg/hr which exceeded the providers ’ prescribed maximum UFR. No supporting documentation of acknowledgement, education, and/or provider notification was observed. 4. On treatment date 01/27/2025, Patient G ’ s prescribed BFR was 450 mL. Review of Patient G ’ s BFR on treatment date 01/27/2025 revealed documented BFR ranged from 200-400 between 02:06 p.m. - 04:41 p.m. No supporting documentation of acknowledgement, education, and/or provider notification was observed. 5. On treatment date 01/27/2025, Patient I ’ s prescribed DFR was 800 mL. Review of Patient G ’ s DFR on treatment date 01/27/2025 revealed documented DFR of 500 mL between 01:06 p.m. -04:04 p.m. No supporting documentation of acknowledgement, education, and/or provider notification was observed. During an interview, the Manager of Clinical Services stated that whenever there are abnormalities or whenever staff members are not able to abide by the prescription, reason and/or discussion with the provider must be documented.”

“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: 47759 Based on record review and observations of care, the facility’s governing body failed to ensure that the clinical staff members complied with the facility’s access assessment and cannulation protocol. This failure placed patients at potential risk for infection. Findings Included: On 02/03/2025 from 11:00 a.m. -12:00 p.m., review of the facility’s policy titled “Arteriovenous Fistula (AVF) or Arteriovenous Graft (AVG) Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” (Policy 1-04-01E) determined that Page 2 provided a list of effective contact time with the minimum contact time as 30 seconds for Providone Iodine and 60 seconds for both ExSept Plus and Isopropyl Alcohol 70%. On 01/28/2025 and 01/29/2025, during observation of AVF/AVG treatment initiation, the surveyor observed the following: 1. On 01/28/2025 at 09:20 a.m., Staff #2 disinfected the patient ’ s access in [Station #13 Machine #4] for 8 seconds total and cannulated. 2. On 01/29/2025 at 09:26 a.m., Staff #1 disinfected the patient ’ s access in [Station #4 Machine #2] for 14 seconds total and cannulated. 3. On 01/29/2025 at 09:50 a.m., Staff #2 disinfected the patient ’ s access in [Station #5 Machine #1] for 13 seconds total and cannulated.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, and review of the facility’s policies and procedures, the medical director failed to ensure that the staff members adhered to their own policies and procedures. This failure posed a potential risk of safety to the patients, and denied patients their rights to a minimum standard of medical care Findings Included: On 02/03/2025, during record review of the facility’s “Medical Director Agreement,” the surveyor determined that “Physician Duties” on page 39 number 7 letter X stated, “In coordination with the Facility Administrator, assure that patient care policies and procedures are followed by each person who treats patients.” The Medical Director’s signature on the “Medical Director Agreement” and interviews conducted on 02/03/2025 at 12:10 p.m. both confirmed awareness of the duties outlined in the agreement. 1. On 01/31/2025, review of the Facility and Community Emergency Preparedness/Emergency Management Plan binder revealed failure to 1. Maintain documentation of the emergency training exercise conducted and 2. Analyze the facility’s response to the emergency training exercise conducted. This finding failed to meet the facility’s policy titled, “Facility Emergency Management Plan” (4-07-01). 2. On 01/30/2025, review of the Fresenius Dialysis Delivery System Clean and Disinfect Log from 10/14/2024 through 01/29/2024 revealed failure to ensure that all staff members followed the implemented machine disinfection procedure. This finding failed to meet the facility’s policy titled “Fresenius Dialysis Delivery System Cleaning and Disinfection Policy” (Policy 1-15-01). 3. On 01/31/2025, review of the facility’s “Vaccination and Surveillance Report” revealed failure to ensure that all susceptible patients were offered Hepatitis B Vaccination. This finding failed to meet the facility’s policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” (Policy 1-05-02). 4. On 01/30/2025, observations of an unaccompanied external personnel in the water room failed to ensure that the water room remained secured and restricted from unauthorized access. This finding failed to meet the facility’s policy titled, “Physical Environment” (Policy 8-04-01). 5. On 01/30/2025, review of the facility’s “Titan Water System Disinfection Log” and “Titan Minncare HD Testing Documentation” revealed failure to ensure 1. that disinfection of the water distribution system occurs on a monthly basis and 2. That staff members document according to policy. This finding failed to meet the facility’s policy titled “Water Treatment System Disinfection” (Policy 1-16-01). 6. On 01/30/2025, review of the “Granuflo (132 Gallon) Batch Production Record” from 11/20/2024-01/29/2024 revealed that on 11/20/2024 and 12/29/2024, the surveyor observed that there was no Licensed Nurse signature verifying the information documented thereby failing to ensure staff compliance in completing mixing log documentation. This finding failed to meet the facility ’ s policy titled “Granuflo Concentrate Dissolution Unit (132 Gallon) Mixing Procedure” (Procedure 1-20-04 A). 7. On 01/29/2025, observations and Staff interviews revealed failure to ensure that pH was performed before starting the treatment of each patient and 2. pH testing was performed according to the direction for use. This finding failed to meet the facility ’ s policy titled “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate.” (Policy 1-03-02). 8. On 01/28/2025 and 01/29/2025, observations and staff interviews revealed failure to ensure that the facility staff operated dialysis machines in accordance with the manufacturer’s recommendations. This finding failed to meet several facility policies. Such as: -“Hemodialysis Delivery System Safety Condition Required During Treatment” (Policy 1-15-10); -“Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate.” (Policy 1-03-02); -“Priming a Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Nipro or Combiset Blood Lines for Subsequent Treatment Shifts.” (Policy 1-03-06W); 9. On 01/30/2025, review of Patient C ’ s medical records revealed failure to conduct and/or obtain a copy of Patient C ’ s history and physical. This finding failed to meet the facility policy titled “Accepting End Stage Kidney Disease Patients for Treatment” (Policy 3-01-03). 10. On 01/31/2025, review of the selected patients treatment flowsheet revealed failure to ensure that the dialysis treatment provided to patients was in accordance with the written prescription. This finding failed to meet the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment.” (Policy 1-03-08). 11. On 01/28/2025 and 01/29/2025, observations of the treatment floor revealed failure to ensure that the clinical staff members complied with the facility’s access assessment and cannulation protocol. This finding failed to meet the facility ’ s policy titled “Arteriovenous Fistula (AVF) or Arteriovenous Graft (AVG) Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” (Policy 1-04-01E).”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 47759 Based on record review, the facility’s governing body failed to ensure an adequate number of qualified and trained staff to meet the needs of the patients. This failure placed the patients at potential risk and denied their rights to a minimum standard of medical care. Findings Include: The Code of Maryland Regulations 10.05.04.06C (Dialysis Monitoring for Freestanding Kidney Dialysis Centers) states: (a) In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be: (i) A minimum of one staff member to three participants; and (ii) Sufficient to meet the needs of patients....(c) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. (d) The charge nurse may not be included in the staffing ratio except: (i) When there are nine or fewer patients; or (ii) In the event of an emergency....Staffing Exception Reporting. (a) ... The report shall include, at a minimum: (i) The date and shift of the exception; (ii) A description of the emergency staffing situation;(iii) Actions taken in response; and (iv) Any measures taken to ensure the center’s future compliance. (b) The exception reporting protocol shall be included in the center’s quality assurance process. On 01/28/2025, a review of the facility’s staffing report from 01/01/2025 through 01/25/2025 revealed that staffing ratios did not meet the requirements on the following dates and shifts: 1. 01/02/2025, shifts 1 and 2. 2. 01/03/2025, shifts 1 and 2. 3. 01/04/2025, shift 1. 4. 01/09/2025, shifts 1 and 2. 5. 01/20/2025, shifts 1 and 2. 6. 01/21/2025, shift 1. 7. 01/25/2025, shifts 1 and 2.”